HT Staff

 

 

Lenalidomide (Revlimid)

Photo courtesy of Celgene

 

Initial results from the phase 3 REMARC study suggest that lenalidomide (Revlimid) maintenance does not prolong overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) who have responded to first-line treatment with R-CHOP.

Based on these results, Celgene Corporation, the company developing lenalidomide, said it does not plan to seek approval for the drug for this indication.

REMARC is a randomized, double-blind study designed to compare lenalidomide maintenance to placebo in 650 patients responding to induction therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).

Patients in REMARC had received 6 to 8 cycles of the R-CHOP-14 regimen, 6 to 8 cycles of the R-CHOP-21 regimen, or 6 cycles of R-CHOP-14/R-CHOP-21 completed by 2 cycles of rituximab alone.

The primary endpoint of the study—a significant improvement in progression-free survival for patients receiving lenalidomide—was met.

However, the interim analysis of OS showed no benefit for patients in the lenalidomide arm.

Celgene said that, based on these results, the company is not planning to seek approval for lenalidomide as maintenance in this patient population.

“We are continuing to partner with LYSA [Lymphoma Study Association] to complete the analyses of the REMARC study,” said Michael Pehl, of Celgene.

“We remain committed to finishing the 4 ongoing phase 3 trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma.”

The REMARC study is part of a research program focused on non-Hodgkin lymphoma. In addition to the REMARC study, lenalidomide is also being evaluated in:

• The RELEVANCE study—in combination with rituximab in previously untreated follicular lymphoma (FL)
• The AUGMENT study—in combination with rituximab in relapsed/refractory FL and marginal zone lymphoma
• The MAGNIFY study—in combination with rituximab in relapsed/refractory FL, marginal zone lymphoma, and mantle cell lymphoma
• The ROBUST study—in combination with R-CHOP in previously untreated ABC-subtype DLBCL.

Data from RELEVANCE and AUGMENT are expected in the first and second half of 2017, respectively.

 

 

Lenalidomide (Revlimid)

Photo courtesy of Celgene

 

Initial results from the phase 3 REMARC study suggest that lenalidomide (Revlimid) maintenance does not prolong overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) who have responded to first-line treatment with R-CHOP.

Based on these results, Celgene Corporation, the company developing lenalidomide, said it does not plan to seek approval for the drug for this indication.

REMARC is a randomized, double-blind study designed to compare lenalidomide maintenance to placebo in 650 patients responding to induction therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).

Patients in REMARC had received 6 to 8 cycles of the R-CHOP-14 regimen, 6 to 8 cycles of the R-CHOP-21 regimen, or 6 cycles of R-CHOP-14/R-CHOP-21 completed by 2 cycles of rituximab alone.

The primary endpoint of the study—a significant improvement in progression-free survival for patients receiving lenalidomide—was met.

However, the interim analysis of OS showed no benefit for patients in the lenalidomide arm.

Celgene said that, based on these results, the company is not planning to seek approval for lenalidomide as maintenance in this patient population.

“We are continuing to partner with LYSA [Lymphoma Study Association] to complete the analyses of the REMARC study,” said Michael Pehl, of Celgene.

“We remain committed to finishing the 4 ongoing phase 3 trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma.”

The REMARC study is part of a research program focused on non-Hodgkin lymphoma. In addition to the REMARC study, lenalidomide is also being evaluated in:

• The RELEVANCE study—in combination with rituximab in previously untreated follicular lymphoma (FL)
• The AUGMENT study—in combination with rituximab in relapsed/refractory FL and marginal zone lymphoma
• The MAGNIFY study—in combination with rituximab in relapsed/refractory FL, marginal zone lymphoma, and mantle cell lymphoma
• The ROBUST study—in combination with R-CHOP in previously untreated ABC-subtype DLBCL.

Data from RELEVANCE and AUGMENT are expected in the first and second half of 2017, respectively.

 

 

Lenalidomide (Revlimid)

Photo courtesy of Celgene

 

Initial results from the phase 3 REMARC study suggest that lenalidomide (Revlimid) maintenance does not prolong overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) who have responded to first-line treatment with R-CHOP.

Based on these results, Celgene Corporation, the company developing lenalidomide, said it does not plan to seek approval for the drug for this indication.

REMARC is a randomized, double-blind study designed to compare lenalidomide maintenance to placebo in 650 patients responding to induction therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).

Patients in REMARC had received 6 to 8 cycles of the R-CHOP-14 regimen, 6 to 8 cycles of the R-CHOP-21 regimen, or 6 cycles of R-CHOP-14/R-CHOP-21 completed by 2 cycles of rituximab alone.

The primary endpoint of the study—a significant improvement in progression-free survival for patients receiving lenalidomide—was met.

However, the interim analysis of OS showed no benefit for patients in the lenalidomide arm.

Celgene said that, based on these results, the company is not planning to seek approval for lenalidomide as maintenance in this patient population.

“We are continuing to partner with LYSA [Lymphoma Study Association] to complete the analyses of the REMARC study,” said Michael Pehl, of Celgene.

“We remain committed to finishing the 4 ongoing phase 3 trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma.”

The REMARC study is part of a research program focused on non-Hodgkin lymphoma. In addition to the REMARC study, lenalidomide is also being evaluated in:

• The RELEVANCE study—in combination with rituximab in previously untreated follicular lymphoma (FL)
• The AUGMENT study—in combination with rituximab in relapsed/refractory FL and marginal zone lymphoma
• The MAGNIFY study—in combination with rituximab in relapsed/refractory FL, marginal zone lymphoma, and mantle cell lymphoma
• The ROBUST study—in combination with R-CHOP in previously untreated ABC-subtype DLBCL.

Data from RELEVANCE and AUGMENT are expected in the first and second half of 2017, respectively.

Daratumumab (Darzalex)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for daratumumab (Darzalex), a CD38-directed monoclonal antibody (mAb), as part of combination therapy for patients with multiple myeloma (MM).

The designation is for daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of MM patients who have received at least 1 prior therapy.

This is the second breakthrough designation the FDA has granted to daratumumab.

The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.

To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

In May 2013, the FDA granted daratumumab breakthrough designation for the treatment of MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

In November 2015, daratumumab received accelerated approval from the FDA for this indication. Continued approval of the mAb may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Phase 3 trials

The newest breakthrough designation for daratumumab was based on data from two phase 3 studies—CASTOR (MMY3004) and POLLUX (MMY3003). Both studies were sponsored by Janssen Biotech, Inc., the company developing daratumumab.

In the CASTOR trial, researchers compared daratumumab-bortezomib-dexamethasone to bortezomib-dexamethasone in MM patients who had received at least 1 prior therapy.

The researchers said the addition of daratumumab significantly improved progression-free survival without increasing the cumulative toxicity or the toxicity of the bortezomib-dexamethasone combination.

Results from this trial were presented at the 2016 ASCO Annual Meeting.

In the POLLUX trial, researchers compared daratumumab-lenalidomide-dexamethasone to lenalidomide-dexamethasone in MM patients who had received at least 1 prior therapy.

According to the researchers, daratumumab-lenalidomide-dexamethasone conferred the highest response rate reported to date in the treatment of relapsed/refractory MM, significantly improved progression-free survival compared to lenalidomide-dexamethasone, and had a manageable safety profile.

These results were presented at the 21st Congress of the European Hematology Association.

Daratumumab (Darzalex)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for daratumumab (Darzalex), a CD38-directed monoclonal antibody (mAb), as part of combination therapy for patients with multiple myeloma (MM).

The designation is for daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of MM patients who have received at least 1 prior therapy.

This is the second breakthrough designation the FDA has granted to daratumumab.

The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.

To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

In May 2013, the FDA granted daratumumab breakthrough designation for the treatment of MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

In November 2015, daratumumab received accelerated approval from the FDA for this indication. Continued approval of the mAb may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Phase 3 trials

The newest breakthrough designation for daratumumab was based on data from two phase 3 studies—CASTOR (MMY3004) and POLLUX (MMY3003). Both studies were sponsored by Janssen Biotech, Inc., the company developing daratumumab.

In the CASTOR trial, researchers compared daratumumab-bortezomib-dexamethasone to bortezomib-dexamethasone in MM patients who had received at least 1 prior therapy.

The researchers said the addition of daratumumab significantly improved progression-free survival without increasing the cumulative toxicity or the toxicity of the bortezomib-dexamethasone combination.

Results from this trial were presented at the 2016 ASCO Annual Meeting.

In the POLLUX trial, researchers compared daratumumab-lenalidomide-dexamethasone to lenalidomide-dexamethasone in MM patients who had received at least 1 prior therapy.

According to the researchers, daratumumab-lenalidomide-dexamethasone conferred the highest response rate reported to date in the treatment of relapsed/refractory MM, significantly improved progression-free survival compared to lenalidomide-dexamethasone, and had a manageable safety profile.

These results were presented at the 21st Congress of the European Hematology Association.

Daratumumab (Darzalex)

Photo courtesy of Janssen

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for daratumumab (Darzalex), a CD38-directed monoclonal antibody (mAb), as part of combination therapy for patients with multiple myeloma (MM).

The designation is for daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for the treatment of MM patients who have received at least 1 prior therapy.

This is the second breakthrough designation the FDA has granted to daratumumab.

The FDA’s breakthrough designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.

To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

In May 2013, the FDA granted daratumumab breakthrough designation for the treatment of MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

In November 2015, daratumumab received accelerated approval from the FDA for this indication. Continued approval of the mAb may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Phase 3 trials

The newest breakthrough designation for daratumumab was based on data from two phase 3 studies—CASTOR (MMY3004) and POLLUX (MMY3003). Both studies were sponsored by Janssen Biotech, Inc., the company developing daratumumab.

In the CASTOR trial, researchers compared daratumumab-bortezomib-dexamethasone to bortezomib-dexamethasone in MM patients who had received at least 1 prior therapy.

The researchers said the addition of daratumumab significantly improved progression-free survival without increasing the cumulative toxicity or the toxicity of the bortezomib-dexamethasone combination.

Results from this trial were presented at the 2016 ASCO Annual Meeting.

In the POLLUX trial, researchers compared daratumumab-lenalidomide-dexamethasone to lenalidomide-dexamethasone in MM patients who had received at least 1 prior therapy.

According to the researchers, daratumumab-lenalidomide-dexamethasone conferred the highest response rate reported to date in the treatment of relapsed/refractory MM, significantly improved progression-free survival compared to lenalidomide-dexamethasone, and had a manageable safety profile.

These results were presented at the 21st Congress of the European Hematology Association.

Nickhill Bhakta, MD

Photo courtesy of St. Jude

Children’s Research Hospital

and Seth Dixon

New research has shown that survivors of pediatric Hodgkin lymphoma (HL) are more likely to have chronic cardiovascular conditions than adults who did not have cancer in childhood.

And cardiovascular conditions are more severe among HL survivors than the general population.

Investigators believe this research, published in The Lancet Oncology, should aid efforts to reduce and better manage the late effects of cancer treatment.

For this study, the investigators used a measurement called “cumulative burden” to better capture the distribution and magnitude of chronic disease in childhood cancer survivors.

The metric showed that, by age 50, HL survivors had more than twice as many cardiovascular problems as adults who had not had cancer as children. HL survivors were also 5 times more likely to have severe, life-threatening, or fatal heart conditions.

“With cure rates for pediatric cancer at historic highs, the question becomes, ‘What is the legacy of that cure?’” said study author Nickhill Bhakta, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“We are doing a better job of keeping patients alive, but are we doing a better job at addressing the chronic diseases that are sometimes the price of that cure? Cumulative burden is a new tool for studying chronic illness in childhood cancer survivors or any patient population with significant morbidity, such as diabetes or HIV/AIDS.”

Unlike statistical methods that count health conditions once at diagnosis, cumulative burden tracks individuals’ multiple, recurring treatment-related health conditions.

Dr Bhakta and his colleagues focused on calculating the cumulative burden of cardiovascular disease in 670 pediatric HL survivors. The subjects were at least 18 years old and had survived at least 10 years beyond their cancer diagnoses.

The participants had been assessed for 22 chronic cardiovascular conditions, including heart attacks, hypertension, arrhythmias, and structural heart defects. Investigators used those and other clinical findings to calculate the cumulative burden by tracking the incidence and severity of cardiovascular disease.

The team also determined the cumulative burden for a comparison group of 272 community volunteers who underwent the same health assessments. The volunteers were similar in age and gender to the HL survivors but had no history of childhood cancer.

The analysis showed that the cumulative burden of cardiovascular disease, including severe and life-threatening conditions, was greater among HL survivors at 30 and 50 years of age than among the comparison group. In fact, the cumulative burden of the most serious heart problems, including heart attacks, was similar for 30-year-old HL survivors and 50-year-old community volunteers.

At age 50, 45.5% of HL survivors had developed at least one grade 3-5 cardiovascular condition, compared to 15.7% of the control subjects.

The HL survivors had a cumulative burden of 430.6 grade 1-5 cardiovascular conditions per 100 individuals and 100.8 grade 3-5 cardiovascular conditions per 100 individuals. In comparison, controls had 227.4 grade 1-5 conditions and 17.0 grade 3-5 conditions per 100 individuals.

The investigators noted that severe, chronic heart conditions became more common with age in both groups, but serious problems accumulated more rapidly in HL survivors.

“Survivors tended to have more severe disease across the lifespan and likely need an individualized screening and treatment plan,” Dr Bhakta said.

He added that the results of this study highlight trade-offs to consider in designing future clinical trials. For example, the investigators found that reducing the dose of anthracyclines will lower the rate, but not the severity, of cardiovascular disease in pediatric and young adult HL survivors.

In contrast, lowering the heart radiation dose will not significantly lower the rate of cardiovascular disease, but it will reduce the severity.

“Cumulative burden provides us with a global view of tradeoffs between different treatment late effects that must be considered when designing new interventions,” Dr Bhakta concluded.

Nickhill Bhakta, MD

Photo courtesy of St. Jude

Children’s Research Hospital

and Seth Dixon

New research has shown that survivors of pediatric Hodgkin lymphoma (HL) are more likely to have chronic cardiovascular conditions than adults who did not have cancer in childhood.

And cardiovascular conditions are more severe among HL survivors than the general population.

Investigators believe this research, published in The Lancet Oncology, should aid efforts to reduce and better manage the late effects of cancer treatment.

For this study, the investigators used a measurement called “cumulative burden” to better capture the distribution and magnitude of chronic disease in childhood cancer survivors.

The metric showed that, by age 50, HL survivors had more than twice as many cardiovascular problems as adults who had not had cancer as children. HL survivors were also 5 times more likely to have severe, life-threatening, or fatal heart conditions.

“With cure rates for pediatric cancer at historic highs, the question becomes, ‘What is the legacy of that cure?’” said study author Nickhill Bhakta, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“We are doing a better job of keeping patients alive, but are we doing a better job at addressing the chronic diseases that are sometimes the price of that cure? Cumulative burden is a new tool for studying chronic illness in childhood cancer survivors or any patient population with significant morbidity, such as diabetes or HIV/AIDS.”

Unlike statistical methods that count health conditions once at diagnosis, cumulative burden tracks individuals’ multiple, recurring treatment-related health conditions.

Dr Bhakta and his colleagues focused on calculating the cumulative burden of cardiovascular disease in 670 pediatric HL survivors. The subjects were at least 18 years old and had survived at least 10 years beyond their cancer diagnoses.

The participants had been assessed for 22 chronic cardiovascular conditions, including heart attacks, hypertension, arrhythmias, and structural heart defects. Investigators used those and other clinical findings to calculate the cumulative burden by tracking the incidence and severity of cardiovascular disease.

The team also determined the cumulative burden for a comparison group of 272 community volunteers who underwent the same health assessments. The volunteers were similar in age and gender to the HL survivors but had no history of childhood cancer.

The analysis showed that the cumulative burden of cardiovascular disease, including severe and life-threatening conditions, was greater among HL survivors at 30 and 50 years of age than among the comparison group. In fact, the cumulative burden of the most serious heart problems, including heart attacks, was similar for 30-year-old HL survivors and 50-year-old community volunteers.

At age 50, 45.5% of HL survivors had developed at least one grade 3-5 cardiovascular condition, compared to 15.7% of the control subjects.

The HL survivors had a cumulative burden of 430.6 grade 1-5 cardiovascular conditions per 100 individuals and 100.8 grade 3-5 cardiovascular conditions per 100 individuals. In comparison, controls had 227.4 grade 1-5 conditions and 17.0 grade 3-5 conditions per 100 individuals.

The investigators noted that severe, chronic heart conditions became more common with age in both groups, but serious problems accumulated more rapidly in HL survivors.

“Survivors tended to have more severe disease across the lifespan and likely need an individualized screening and treatment plan,” Dr Bhakta said.

He added that the results of this study highlight trade-offs to consider in designing future clinical trials. For example, the investigators found that reducing the dose of anthracyclines will lower the rate, but not the severity, of cardiovascular disease in pediatric and young adult HL survivors.

In contrast, lowering the heart radiation dose will not significantly lower the rate of cardiovascular disease, but it will reduce the severity.

“Cumulative burden provides us with a global view of tradeoffs between different treatment late effects that must be considered when designing new interventions,” Dr Bhakta concluded.

Nickhill Bhakta, MD

Photo courtesy of St. Jude

Children’s Research Hospital

and Seth Dixon

New research has shown that survivors of pediatric Hodgkin lymphoma (HL) are more likely to have chronic cardiovascular conditions than adults who did not have cancer in childhood.

And cardiovascular conditions are more severe among HL survivors than the general population.

Investigators believe this research, published in The Lancet Oncology, should aid efforts to reduce and better manage the late effects of cancer treatment.

For this study, the investigators used a measurement called “cumulative burden” to better capture the distribution and magnitude of chronic disease in childhood cancer survivors.

The metric showed that, by age 50, HL survivors had more than twice as many cardiovascular problems as adults who had not had cancer as children. HL survivors were also 5 times more likely to have severe, life-threatening, or fatal heart conditions.

“With cure rates for pediatric cancer at historic highs, the question becomes, ‘What is the legacy of that cure?’” said study author Nickhill Bhakta, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“We are doing a better job of keeping patients alive, but are we doing a better job at addressing the chronic diseases that are sometimes the price of that cure? Cumulative burden is a new tool for studying chronic illness in childhood cancer survivors or any patient population with significant morbidity, such as diabetes or HIV/AIDS.”

Unlike statistical methods that count health conditions once at diagnosis, cumulative burden tracks individuals’ multiple, recurring treatment-related health conditions.

Dr Bhakta and his colleagues focused on calculating the cumulative burden of cardiovascular disease in 670 pediatric HL survivors. The subjects were at least 18 years old and had survived at least 10 years beyond their cancer diagnoses.

The participants had been assessed for 22 chronic cardiovascular conditions, including heart attacks, hypertension, arrhythmias, and structural heart defects. Investigators used those and other clinical findings to calculate the cumulative burden by tracking the incidence and severity of cardiovascular disease.

The team also determined the cumulative burden for a comparison group of 272 community volunteers who underwent the same health assessments. The volunteers were similar in age and gender to the HL survivors but had no history of childhood cancer.

The analysis showed that the cumulative burden of cardiovascular disease, including severe and life-threatening conditions, was greater among HL survivors at 30 and 50 years of age than among the comparison group. In fact, the cumulative burden of the most serious heart problems, including heart attacks, was similar for 30-year-old HL survivors and 50-year-old community volunteers.

At age 50, 45.5% of HL survivors had developed at least one grade 3-5 cardiovascular condition, compared to 15.7% of the control subjects.

The HL survivors had a cumulative burden of 430.6 grade 1-5 cardiovascular conditions per 100 individuals and 100.8 grade 3-5 cardiovascular conditions per 100 individuals. In comparison, controls had 227.4 grade 1-5 conditions and 17.0 grade 3-5 conditions per 100 individuals.

The investigators noted that severe, chronic heart conditions became more common with age in both groups, but serious problems accumulated more rapidly in HL survivors.

“Survivors tended to have more severe disease across the lifespan and likely need an individualized screening and treatment plan,” Dr Bhakta said.

He added that the results of this study highlight trade-offs to consider in designing future clinical trials. For example, the investigators found that reducing the dose of anthracyclines will lower the rate, but not the severity, of cardiovascular disease in pediatric and young adult HL survivors.

In contrast, lowering the heart radiation dose will not significantly lower the rate of cardiovascular disease, but it will reduce the severity.

“Cumulative burden provides us with a global view of tradeoffs between different treatment late effects that must be considered when designing new interventions,” Dr Bhakta concluded.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted premarket clearance for the QuantideX® qPCR BCR-ABL IS Kit, a tool used to monitor molecular response (MR) in patients with chronic myeloid leukemia (CML).

The product is a quantitative polymerase chain reaction (qPCR)-based in vitro diagnostic test that quantifies BCR-ABL1 and ABL1 transcripts in total RNA from the whole blood of t(9;22)-positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

The QuantideX® qPCR BCR-ABL IS Kit is not designed to diagnose CML or monitor rare transcripts resulting from t(9;22).

The kit was cleared to run on the Applied Biosystems® 7500 Fast DX Real-Time PCR Instrument. Results are reported in International Scale (IS) values.

The QuantideX® qPCR BCR-ABL IS Kit was subjected to analytic and clinical review through the FDA’s de novo 510(k) premarket review pathway and secured clearance with a limit of detection of MR 4.7/0.002% IS (4.7 log molecular reduction from 100% IS).

The limit of detection was determined using real human RNA, not human-derived cell lines, ensuring that the assay reproducibly detects BCR-ABL1 RNA in at least 95% of patients at MR 4.7.

“In evaluating the QuantideX® qPCR BCR-ABL IS Kit, we confirmed the high level of sensitivity achieved for human clinical samples measured in our laboratory at MR 4.7 (0.002% IS),” said Y. Lynn. Wang, MD, PhD, of the University of Chicago Comprehensive Cancer Center.

“The configuration of the assay—multiplexed, single-lot reagents, efficient workflow, and direct IS reporting—provided the robustness, sensitivity, and data quality we believe to be unprecedented in the market today. The high level of sensitivity will contribute to the assessment of the depth and duration of clinical response to [tyrosine kinase inhibitors] and experimental therapies.”

The QuantideX® qPCR BCR-ABL IS Kit is now available for order in the US and Europe. The kit is a product of Asuragen, Inc.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted premarket clearance for the QuantideX® qPCR BCR-ABL IS Kit, a tool used to monitor molecular response (MR) in patients with chronic myeloid leukemia (CML).

The product is a quantitative polymerase chain reaction (qPCR)-based in vitro diagnostic test that quantifies BCR-ABL1 and ABL1 transcripts in total RNA from the whole blood of t(9;22)-positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

The QuantideX® qPCR BCR-ABL IS Kit is not designed to diagnose CML or monitor rare transcripts resulting from t(9;22).

The kit was cleared to run on the Applied Biosystems® 7500 Fast DX Real-Time PCR Instrument. Results are reported in International Scale (IS) values.

The QuantideX® qPCR BCR-ABL IS Kit was subjected to analytic and clinical review through the FDA’s de novo 510(k) premarket review pathway and secured clearance with a limit of detection of MR 4.7/0.002% IS (4.7 log molecular reduction from 100% IS).

The limit of detection was determined using real human RNA, not human-derived cell lines, ensuring that the assay reproducibly detects BCR-ABL1 RNA in at least 95% of patients at MR 4.7.

“In evaluating the QuantideX® qPCR BCR-ABL IS Kit, we confirmed the high level of sensitivity achieved for human clinical samples measured in our laboratory at MR 4.7 (0.002% IS),” said Y. Lynn. Wang, MD, PhD, of the University of Chicago Comprehensive Cancer Center.

“The configuration of the assay—multiplexed, single-lot reagents, efficient workflow, and direct IS reporting—provided the robustness, sensitivity, and data quality we believe to be unprecedented in the market today. The high level of sensitivity will contribute to the assessment of the depth and duration of clinical response to [tyrosine kinase inhibitors] and experimental therapies.”

The QuantideX® qPCR BCR-ABL IS Kit is now available for order in the US and Europe. The kit is a product of Asuragen, Inc.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted premarket clearance for the QuantideX® qPCR BCR-ABL IS Kit, a tool used to monitor molecular response (MR) in patients with chronic myeloid leukemia (CML).

The product is a quantitative polymerase chain reaction (qPCR)-based in vitro diagnostic test that quantifies BCR-ABL1 and ABL1 transcripts in total RNA from the whole blood of t(9;22)-positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

The QuantideX® qPCR BCR-ABL IS Kit is not designed to diagnose CML or monitor rare transcripts resulting from t(9;22).

The kit was cleared to run on the Applied Biosystems® 7500 Fast DX Real-Time PCR Instrument. Results are reported in International Scale (IS) values.

The QuantideX® qPCR BCR-ABL IS Kit was subjected to analytic and clinical review through the FDA’s de novo 510(k) premarket review pathway and secured clearance with a limit of detection of MR 4.7/0.002% IS (4.7 log molecular reduction from 100% IS).

The limit of detection was determined using real human RNA, not human-derived cell lines, ensuring that the assay reproducibly detects BCR-ABL1 RNA in at least 95% of patients at MR 4.7.

“In evaluating the QuantideX® qPCR BCR-ABL IS Kit, we confirmed the high level of sensitivity achieved for human clinical samples measured in our laboratory at MR 4.7 (0.002% IS),” said Y. Lynn. Wang, MD, PhD, of the University of Chicago Comprehensive Cancer Center.

“The configuration of the assay—multiplexed, single-lot reagents, efficient workflow, and direct IS reporting—provided the robustness, sensitivity, and data quality we believe to be unprecedented in the market today. The high level of sensitivity will contribute to the assessment of the depth and duration of clinical response to [tyrosine kinase inhibitors] and experimental therapies.”

The QuantideX® qPCR BCR-ABL IS Kit is now available for order in the US and Europe. The kit is a product of Asuragen, Inc.

White leghorn chickens

Photo by Geri Glastra

Research published in Malaria Journal indicates that malaria-transmitting mosquitoes use their sense of smell to avoid feeding on chickens.

Investigators therefore believe that odors emitted by chickens and other animals could provide protection for humans at risk of mosquito-transmitted diseases.

The study showed that Anopheles arabiensis, one of the predominant species of mosquitoes transmitting malaria in sub-Saharan Africa, avoids chickens when looking for hosts to feed on.

And the mosquitoes can distinguish chickens from other animals using their sense of smell.

“We were surprised to find that malaria mosquitoes are repelled by the odors emitted by chickens,” said study author Rickard Ignell, PhD, of the Swedish University of Agricultural Sciences in Alnarp, Sweden.

“This study shows, for the first time, that malaria mosquitoes actively avoid feeding on certain animal species and that this behavior is regulated through odor cues.”

To find out which species the mosquitoes prefer, Dr Ignell and his colleagues collected data on the population of human and domestic animals in 3 Ethiopian villages. People living in these villages share their living quarters with their livestock.

The investigators also collected blood-fed mosquitoes to test for the source of the blood the mosquitoes had consumed.

The team found that An arabiensis strongly prefers human over animal blood when seeking hosts indoors and randomly feeds on cattle, goats, and sheep when outdoors. However, the mosquitoes avoid chickens in both settings, despite their relatively high abundance.

Since mosquitoes select and discriminate between their hosts mainly based on their sense of smell, the investigators collected hair, wool, and feathers from potential host and non-host species to analyze the odor compounds present in them.

Identifying certain compounds that were only present in chicken feathers, the team used these and other compounds obtained from all species to test their ability to repel mosquitoes from mosquito traps.

The traps were set up in 11 thatched houses in one of the villages for a total of 11 days. In each of the houses, a single volunteer between ages 27 and 36 slept under an untreated bed net.

The investigators found that significantly fewer mosquitoes were caught in traps baited with chicken compounds than in control traps. Suspending a living chicken in a cage next to a trap had a similar repellent effect.

Because it feeds indoors and outdoors on various host species, An arabiensis is difficult to control with existing methods, previous research has shown. The results of the current study suggest that, in combination with established control methods, the odors emitted by chickens and other non-host species could prove useful in controlling An arabiensis.

“People in sub-Saharan Africa have suffered considerably under the burden of malaria over an extended period of time, and mosquitoes are becoming increasingly physiologically resistant to pesticides, while also changing their feeding habits, for example, by moving from indoors to outdoors,” Dr Ignell said.

“For this reason, there is a need to develop novel control methods. In our study, we have been able to identify a number of natural odor compounds which could repel host-seeking malaria mosquitoes and prevent them from getting in contact with people.”

White leghorn chickens

Photo by Geri Glastra

Research published in Malaria Journal indicates that malaria-transmitting mosquitoes use their sense of smell to avoid feeding on chickens.

Investigators therefore believe that odors emitted by chickens and other animals could provide protection for humans at risk of mosquito-transmitted diseases.

The study showed that Anopheles arabiensis, one of the predominant species of mosquitoes transmitting malaria in sub-Saharan Africa, avoids chickens when looking for hosts to feed on.

And the mosquitoes can distinguish chickens from other animals using their sense of smell.

“We were surprised to find that malaria mosquitoes are repelled by the odors emitted by chickens,” said study author Rickard Ignell, PhD, of the Swedish University of Agricultural Sciences in Alnarp, Sweden.

“This study shows, for the first time, that malaria mosquitoes actively avoid feeding on certain animal species and that this behavior is regulated through odor cues.”

To find out which species the mosquitoes prefer, Dr Ignell and his colleagues collected data on the population of human and domestic animals in 3 Ethiopian villages. People living in these villages share their living quarters with their livestock.

The investigators also collected blood-fed mosquitoes to test for the source of the blood the mosquitoes had consumed.

The team found that An arabiensis strongly prefers human over animal blood when seeking hosts indoors and randomly feeds on cattle, goats, and sheep when outdoors. However, the mosquitoes avoid chickens in both settings, despite their relatively high abundance.

Since mosquitoes select and discriminate between their hosts mainly based on their sense of smell, the investigators collected hair, wool, and feathers from potential host and non-host species to analyze the odor compounds present in them.

Identifying certain compounds that were only present in chicken feathers, the team used these and other compounds obtained from all species to test their ability to repel mosquitoes from mosquito traps.

The traps were set up in 11 thatched houses in one of the villages for a total of 11 days. In each of the houses, a single volunteer between ages 27 and 36 slept under an untreated bed net.

The investigators found that significantly fewer mosquitoes were caught in traps baited with chicken compounds than in control traps. Suspending a living chicken in a cage next to a trap had a similar repellent effect.

Because it feeds indoors and outdoors on various host species, An arabiensis is difficult to control with existing methods, previous research has shown. The results of the current study suggest that, in combination with established control methods, the odors emitted by chickens and other non-host species could prove useful in controlling An arabiensis.

“People in sub-Saharan Africa have suffered considerably under the burden of malaria over an extended period of time, and mosquitoes are becoming increasingly physiologically resistant to pesticides, while also changing their feeding habits, for example, by moving from indoors to outdoors,” Dr Ignell said.

“For this reason, there is a need to develop novel control methods. In our study, we have been able to identify a number of natural odor compounds which could repel host-seeking malaria mosquitoes and prevent them from getting in contact with people.”

White leghorn chickens

Photo by Geri Glastra

Research published in Malaria Journal indicates that malaria-transmitting mosquitoes use their sense of smell to avoid feeding on chickens.

Investigators therefore believe that odors emitted by chickens and other animals could provide protection for humans at risk of mosquito-transmitted diseases.

The study showed that Anopheles arabiensis, one of the predominant species of mosquitoes transmitting malaria in sub-Saharan Africa, avoids chickens when looking for hosts to feed on.

And the mosquitoes can distinguish chickens from other animals using their sense of smell.

“We were surprised to find that malaria mosquitoes are repelled by the odors emitted by chickens,” said study author Rickard Ignell, PhD, of the Swedish University of Agricultural Sciences in Alnarp, Sweden.

“This study shows, for the first time, that malaria mosquitoes actively avoid feeding on certain animal species and that this behavior is regulated through odor cues.”

To find out which species the mosquitoes prefer, Dr Ignell and his colleagues collected data on the population of human and domestic animals in 3 Ethiopian villages. People living in these villages share their living quarters with their livestock.

The investigators also collected blood-fed mosquitoes to test for the source of the blood the mosquitoes had consumed.

The team found that An arabiensis strongly prefers human over animal blood when seeking hosts indoors and randomly feeds on cattle, goats, and sheep when outdoors. However, the mosquitoes avoid chickens in both settings, despite their relatively high abundance.

Since mosquitoes select and discriminate between their hosts mainly based on their sense of smell, the investigators collected hair, wool, and feathers from potential host and non-host species to analyze the odor compounds present in them.

Identifying certain compounds that were only present in chicken feathers, the team used these and other compounds obtained from all species to test their ability to repel mosquitoes from mosquito traps.

The traps were set up in 11 thatched houses in one of the villages for a total of 11 days. In each of the houses, a single volunteer between ages 27 and 36 slept under an untreated bed net.

The investigators found that significantly fewer mosquitoes were caught in traps baited with chicken compounds than in control traps. Suspending a living chicken in a cage next to a trap had a similar repellent effect.

Because it feeds indoors and outdoors on various host species, An arabiensis is difficult to control with existing methods, previous research has shown. The results of the current study suggest that, in combination with established control methods, the odors emitted by chickens and other non-host species could prove useful in controlling An arabiensis.

“People in sub-Saharan Africa have suffered considerably under the burden of malaria over an extended period of time, and mosquitoes are becoming increasingly physiologically resistant to pesticides, while also changing their feeding habits, for example, by moving from indoors to outdoors,” Dr Ignell said.

“For this reason, there is a need to develop novel control methods. In our study, we have been able to identify a number of natural odor compounds which could repel host-seeking malaria mosquitoes and prevent them from getting in contact with people.”

Pregnant woman

Photo by Nina Matthews

The US Centers for Disease Control and Prevention (CDC) has updated some of its recommendations regarding the Zika virus.

The agency issued an updated interim guidance for healthcare providers caring for pregnant women with possible exposure to Zika virus and an updated interim guidance on preventing sexual transmission of the virus.

The CDC issued these updates based on the accumulating evidence, expert opinion, and knowledge about the risk associated with other viral infections. The CDC said it will continue to make updates as new information becomes available.

Guidance for pregnant women

This updated guidance expands the timeframe during which pregnant women can be tested for Zika virus—with an rRT-PCR test—from 7 days to 14 days after symptoms start. The CDC said this expansion will provide a definite diagnosis for more pregnant women infected with the Zika virus.

Scientists previously thought the virus stays in the blood for about a week after symptoms start. So the first week of illness was thought to be the best time to find evidence of the virus in blood using a Zika-specific test (rRT-PCR).

For patients who visited a healthcare provider more than a week after symptoms started and those who were possibly exposed to Zika but never developed symptoms, healthcare providers could perform Zika virus IgM testing. However, this test might not provide a definite diagnosis, as it can also detect related viruses.

New information has indicated that some infected pregnant women can have evidence of the Zika virus in their blood for longer than 7 days after symptoms begin, and even pregnant women without symptoms can have evidence of the virus in their blood and urine.

Therefore, the updated guidance expands the use of Zika-specific blood testing for a longer period, up to 14 days, in pregnant women with symptoms and advises that pregnant women with possible Zika exposure but no symptoms receive this testing as well.

In addition, if pregnant women visit their healthcare provider after the 14-day testing window and test positive with the IgM test, rRT-PCR testing can now be offered to potentially provide a definite diagnosis.

The CDC’s new guidance also includes recommendations to help healthcare providers better care for their pregnant patients with confirmed or possible Zika infection.

Guidance for sexual transmission

This updated guidance is based on a recently reported case of female-to-male sexual transmission of the Zika virus in New York City and limited human and non-human primate data indicating that Zika virus RNA can be detected in vaginal secretions.

The guidance expands the CDC’s definition of sexual exposure to Zika to include sex without a barrier method (including male or female condoms, among other methods) with any person—male or female—who has traveled to or lives in an area with active Zika virus transmission.

The updated recommendations for pregnant couples include pregnant women with female sex partners who are potentially infected with Zika. The recommendations also provide advice for potentially infected women on how to reduce their risk of sexually transmitting the virus to partners.

Specifically, the CDC recommends that all pregnant women with sex partners who live in or traveled to an area with active Zika virus transmission use condoms during sex or abstain from sex for the remainder of their pregnancy.

All other couples in which a partner has been in an area with active Zika virus transmission can also reduce the risk of sexual transmission by using condoms or abstaining from sex. Sex includes vaginal, anal, and oral sex, and may also include the sharing of sex toys.

Healthcare providers should test all pregnant women who may have been exposed to Zika sexually. Providers should also test patients if they develop symptoms of the Zika virus and report potential sexual exposure to a partner who lives in or traveled to an area with active Zika virus transmission.

The CDC encourages local and state health departments to report potential cases of sexually transmitted Zika virus infection.

Pregnant woman

Photo by Nina Matthews

The US Centers for Disease Control and Prevention (CDC) has updated some of its recommendations regarding the Zika virus.

The agency issued an updated interim guidance for healthcare providers caring for pregnant women with possible exposure to Zika virus and an updated interim guidance on preventing sexual transmission of the virus.

The CDC issued these updates based on the accumulating evidence, expert opinion, and knowledge about the risk associated with other viral infections. The CDC said it will continue to make updates as new information becomes available.

Guidance for pregnant women

This updated guidance expands the timeframe during which pregnant women can be tested for Zika virus—with an rRT-PCR test—from 7 days to 14 days after symptoms start. The CDC said this expansion will provide a definite diagnosis for more pregnant women infected with the Zika virus.

Scientists previously thought the virus stays in the blood for about a week after symptoms start. So the first week of illness was thought to be the best time to find evidence of the virus in blood using a Zika-specific test (rRT-PCR).

For patients who visited a healthcare provider more than a week after symptoms started and those who were possibly exposed to Zika but never developed symptoms, healthcare providers could perform Zika virus IgM testing. However, this test might not provide a definite diagnosis, as it can also detect related viruses.

New information has indicated that some infected pregnant women can have evidence of the Zika virus in their blood for longer than 7 days after symptoms begin, and even pregnant women without symptoms can have evidence of the virus in their blood and urine.

Therefore, the updated guidance expands the use of Zika-specific blood testing for a longer period, up to 14 days, in pregnant women with symptoms and advises that pregnant women with possible Zika exposure but no symptoms receive this testing as well.

In addition, if pregnant women visit their healthcare provider after the 14-day testing window and test positive with the IgM test, rRT-PCR testing can now be offered to potentially provide a definite diagnosis.

The CDC’s new guidance also includes recommendations to help healthcare providers better care for their pregnant patients with confirmed or possible Zika infection.

Guidance for sexual transmission

This updated guidance is based on a recently reported case of female-to-male sexual transmission of the Zika virus in New York City and limited human and non-human primate data indicating that Zika virus RNA can be detected in vaginal secretions.

The guidance expands the CDC’s definition of sexual exposure to Zika to include sex without a barrier method (including male or female condoms, among other methods) with any person—male or female—who has traveled to or lives in an area with active Zika virus transmission.

The updated recommendations for pregnant couples include pregnant women with female sex partners who are potentially infected with Zika. The recommendations also provide advice for potentially infected women on how to reduce their risk of sexually transmitting the virus to partners.

Specifically, the CDC recommends that all pregnant women with sex partners who live in or traveled to an area with active Zika virus transmission use condoms during sex or abstain from sex for the remainder of their pregnancy.

All other couples in which a partner has been in an area with active Zika virus transmission can also reduce the risk of sexual transmission by using condoms or abstaining from sex. Sex includes vaginal, anal, and oral sex, and may also include the sharing of sex toys.

Healthcare providers should test all pregnant women who may have been exposed to Zika sexually. Providers should also test patients if they develop symptoms of the Zika virus and report potential sexual exposure to a partner who lives in or traveled to an area with active Zika virus transmission.

The CDC encourages local and state health departments to report potential cases of sexually transmitted Zika virus infection.

Pregnant woman

Photo by Nina Matthews

The US Centers for Disease Control and Prevention (CDC) has updated some of its recommendations regarding the Zika virus.

The agency issued an updated interim guidance for healthcare providers caring for pregnant women with possible exposure to Zika virus and an updated interim guidance on preventing sexual transmission of the virus.

The CDC issued these updates based on the accumulating evidence, expert opinion, and knowledge about the risk associated with other viral infections. The CDC said it will continue to make updates as new information becomes available.

Guidance for pregnant women

This updated guidance expands the timeframe during which pregnant women can be tested for Zika virus—with an rRT-PCR test—from 7 days to 14 days after symptoms start. The CDC said this expansion will provide a definite diagnosis for more pregnant women infected with the Zika virus.

Scientists previously thought the virus stays in the blood for about a week after symptoms start. So the first week of illness was thought to be the best time to find evidence of the virus in blood using a Zika-specific test (rRT-PCR).

For patients who visited a healthcare provider more than a week after symptoms started and those who were possibly exposed to Zika but never developed symptoms, healthcare providers could perform Zika virus IgM testing. However, this test might not provide a definite diagnosis, as it can also detect related viruses.

New information has indicated that some infected pregnant women can have evidence of the Zika virus in their blood for longer than 7 days after symptoms begin, and even pregnant women without symptoms can have evidence of the virus in their blood and urine.

Therefore, the updated guidance expands the use of Zika-specific blood testing for a longer period, up to 14 days, in pregnant women with symptoms and advises that pregnant women with possible Zika exposure but no symptoms receive this testing as well.

In addition, if pregnant women visit their healthcare provider after the 14-day testing window and test positive with the IgM test, rRT-PCR testing can now be offered to potentially provide a definite diagnosis.

The CDC’s new guidance also includes recommendations to help healthcare providers better care for their pregnant patients with confirmed or possible Zika infection.

Guidance for sexual transmission

This updated guidance is based on a recently reported case of female-to-male sexual transmission of the Zika virus in New York City and limited human and non-human primate data indicating that Zika virus RNA can be detected in vaginal secretions.

The guidance expands the CDC’s definition of sexual exposure to Zika to include sex without a barrier method (including male or female condoms, among other methods) with any person—male or female—who has traveled to or lives in an area with active Zika virus transmission.

The updated recommendations for pregnant couples include pregnant women with female sex partners who are potentially infected with Zika. The recommendations also provide advice for potentially infected women on how to reduce their risk of sexually transmitting the virus to partners.

Specifically, the CDC recommends that all pregnant women with sex partners who live in or traveled to an area with active Zika virus transmission use condoms during sex or abstain from sex for the remainder of their pregnancy.

All other couples in which a partner has been in an area with active Zika virus transmission can also reduce the risk of sexual transmission by using condoms or abstaining from sex. Sex includes vaginal, anal, and oral sex, and may also include the sharing of sex toys.

Healthcare providers should test all pregnant women who may have been exposed to Zika sexually. Providers should also test patients if they develop symptoms of the Zika virus and report potential sexual exposure to a partner who lives in or traveled to an area with active Zika virus transmission.

The CDC encourages local and state health departments to report potential cases of sexually transmitted Zika virus infection.

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that delirium is relatively frequent and underdiagnosed in patients with advanced cancer visiting the emergency department.

The research showed that delirium was similarly common among older and younger patients.

According to researchers, this suggests that, in the setting of advanced cancer, all patients should be considered at higher risk for delirium.

The researchers reported their findings in Cancer.

For this study, the team assessed a random sample of 243 advanced cancer patients who presented to the emergency department. They were 19 to 89 years old.

All patients were assessed with 2 methods: the Confusion Assessment Method (CAM) to screen for delirium and the Memorial Delirium Assessment Scale (MDAS) to measure delirium severity (mild ≤15, moderate 16-22, and severe ≥23).

In all, 22 patients (9%) had CAM-positive delirium and a median MDAS score of 14. Among CAM-positive patients, delirium was mild in 18 (82%) and moderate in 4 (18%) according to the MDAS.

Of the 99 patients age 65 and older, 10 (10%) had CAM-positive delirium, compared with 12 (8%) of 144 patients younger than 65.

Emergency department physicians failed to detect delirium in 9 (41%) CAM-positive delirious patients.

“We found evidence of delirium in 1 of every 10 patients with advanced cancer who are treated in the emergency department,” said study author Knox Todd, MD, of The University of Texas MD Anderson Cancer Center in Houston.

“Given that we could only study patients who were able to give consent to enter our study, even 10% is likely to be a low estimate. We also identified many psychoactive medications that could have contributed to delirium, and sharing this information with treating oncologists may help them avoid such complications in the next patient they treat.”

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that delirium is relatively frequent and underdiagnosed in patients with advanced cancer visiting the emergency department.

The research showed that delirium was similarly common among older and younger patients.

According to researchers, this suggests that, in the setting of advanced cancer, all patients should be considered at higher risk for delirium.

The researchers reported their findings in Cancer.

For this study, the team assessed a random sample of 243 advanced cancer patients who presented to the emergency department. They were 19 to 89 years old.

All patients were assessed with 2 methods: the Confusion Assessment Method (CAM) to screen for delirium and the Memorial Delirium Assessment Scale (MDAS) to measure delirium severity (mild ≤15, moderate 16-22, and severe ≥23).

In all, 22 patients (9%) had CAM-positive delirium and a median MDAS score of 14. Among CAM-positive patients, delirium was mild in 18 (82%) and moderate in 4 (18%) according to the MDAS.

Of the 99 patients age 65 and older, 10 (10%) had CAM-positive delirium, compared with 12 (8%) of 144 patients younger than 65.

Emergency department physicians failed to detect delirium in 9 (41%) CAM-positive delirious patients.

“We found evidence of delirium in 1 of every 10 patients with advanced cancer who are treated in the emergency department,” said study author Knox Todd, MD, of The University of Texas MD Anderson Cancer Center in Houston.

“Given that we could only study patients who were able to give consent to enter our study, even 10% is likely to be a low estimate. We also identified many psychoactive medications that could have contributed to delirium, and sharing this information with treating oncologists may help them avoid such complications in the next patient they treat.”

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that delirium is relatively frequent and underdiagnosed in patients with advanced cancer visiting the emergency department.

The research showed that delirium was similarly common among older and younger patients.

According to researchers, this suggests that, in the setting of advanced cancer, all patients should be considered at higher risk for delirium.

The researchers reported their findings in Cancer.

For this study, the team assessed a random sample of 243 advanced cancer patients who presented to the emergency department. They were 19 to 89 years old.

All patients were assessed with 2 methods: the Confusion Assessment Method (CAM) to screen for delirium and the Memorial Delirium Assessment Scale (MDAS) to measure delirium severity (mild ≤15, moderate 16-22, and severe ≥23).

In all, 22 patients (9%) had CAM-positive delirium and a median MDAS score of 14. Among CAM-positive patients, delirium was mild in 18 (82%) and moderate in 4 (18%) according to the MDAS.

Of the 99 patients age 65 and older, 10 (10%) had CAM-positive delirium, compared with 12 (8%) of 144 patients younger than 65.

Emergency department physicians failed to detect delirium in 9 (41%) CAM-positive delirious patients.

“We found evidence of delirium in 1 of every 10 patients with advanced cancer who are treated in the emergency department,” said study author Knox Todd, MD, of The University of Texas MD Anderson Cancer Center in Houston.

“Given that we could only study patients who were able to give consent to enter our study, even 10% is likely to be a low estimate. We also identified many psychoactive medications that could have contributed to delirium, and sharing this information with treating oncologists may help them avoid such complications in the next patient they treat.”

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.