Mary Jo Dales

CHICAGO – Dr. Roy Herbst of Yale University discusses early results for MPDL3280A, a new PD-L1 antibody for the treatment of non-small cell lung cancer; he also gives his take on other exciting lung cancer data being presented at the annual meeting of the American Society of Clinical Oncology.

CHICAGO – Dr. Roy Herbst of Yale University discusses early results for MPDL3280A, a new PD-L1 antibody for the treatment of non-small cell lung cancer; he also gives his take on other exciting lung cancer data being presented at the annual meeting of the American Society of Clinical Oncology.

CHICAGO – Dr. Roy Herbst of Yale University discusses early results for MPDL3280A, a new PD-L1 antibody for the treatment of non-small cell lung cancer; he also gives his take on other exciting lung cancer data being presented at the annual meeting of the American Society of Clinical Oncology.

CHICAGO – Combining two approved therapies – GM-CSF and ipilimumab – extended overall survival rates by 35% and resulted in fewer grade 3-5 adverse events when compared with ipilimumab alone in a randomized study of 245 patients with metastatic melanoma.

At 1 year, the overall survival rate in the combination therapy group was 69%, with a median follow-up of nearly 18 months. At 1 year, survival in the ipilimumab-only group was 53% with a median follow-up of nearly 13 months, Dr. F. Stephen Hodi, Jr. reported at the annual meeting of the American Society of Clinical Oncology.

This is the first phase II trial to look at ipilimumab (Yervoy, Bristol-Myers Squibb) and the granulocyte macrophage colony-stimulating factor (GM-CSF) sargramostim (Leukine, Sanofi) in combination in any cancer, said Dr. Hodi, the principal investigator for the trial, which was conducted by the ECOG-ACRIN Cancer Research Group (formerly the Eastern Cooperative Oncology Group) trial. In this study, ipilimumab was used at a dose of 10 mg/kg, which is higher than the FDA-approved dose of 3 mg/kg.

"We are waiting for the data to mature in ongoing studies examining the relative efficacy of 3 mg/kg and 10 mg/kg dosing," said Dr. Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston.

The results in the current trial are another indication of the impact that immunotherapy can have for patients with advanced melanoma. Since both GM-CSF and ipilimumab are commercially available, oncologists need to determine the best way to apply these findings in everyday practice. The next step will then be to define the role of GM-CSF in combination with other immune checkpoint targeting drugs, such as therapies that target the PD-1 and PD-L1 pathway, he said.

"We have been using GM-CSF in melanoma as a stand-alone therapy," Dr. Lynn M. Schuchter, the C. Willard Robinson Professor of Hematology-Oncology at the University of Pennsylvania, Philadelphia, and an expert on melanoma, said at a press conference where the study results were announced. "It will be interesting to see if payers will cover this (combination treatment)."

Ipilimumab targets CTLA-4, a protein that keeps immune T-cells in an inactive state. GM-CSF is a growth factor commonly used to boost white blood cell counts after chemotherapy or stem cell transplantation.

For this study, 245 patients were randomized to receive ipilimumab plus GM-CSF or ipilimumab alone. All study participants were in otherwise good health, with an ECOG performance status of 0-1 and adequate end-organ function, no autoimmune disease, and no prior use of CTLA-4 blockade or CD137 agonists. All had radiographically measurable metastatic melanoma, but with no CNS metastases, and had received up to one prior treatment over 4 weeks before starting in the trial.

The 123 patients randomized to the combination therapy were given sargramostim at 250 micrograms injected subcutaneously on day 1-14 of a 21 day cycle. For induction therapy, ipilimumab was given at a dose of 10 mg/kg intravenously once every 3 weeks for four cycles as induction therapy and once every 12 weeks as maintenance therapy. The 122 patients randomized to ipilimumab alone received the drug on the same schedule.

In both study arms, tumor shrinkage rates were comparable at 11% and 14%, and progression-free survival was similar at about 3 months. But the overall survival rate was longer in the combination treatment arm. One year after the start of therapy and with a median follow-up of 13.3 months, 69% of patients given the combination therapy and 53% of those who got ipilimumab alone were still alive, for a 35% lower risk of death with the combination therapy (hazard ratio, 0.64; P = .014).

Additionally, the combination treatment was associated with fewer serious side effects, compared with ipilimumab alone. The most significant differences were in lung and gastrointestinal toxicities.

Grade 3-5 adverse events occurred in 45% of patients given the combination therapy and in 57% given ipilimumab alone (p2 = 0.078). There were two possible treatment-related deaths in the combination arm (one colonic perforation and one cardiac arrest) and 7 possible treatment-related deaths in the ipilimumab-only arm: (two cases of multi-organ failure, two colonic perforations, one case of liver failure, and two cases of respiratory failure).

The research was supported in part by the National Cancer Institute (Cancer Therapy Evaluation Program), Sanofi, and Bristol-Myers Squibb. Dr. Hodi disclosed receiving research funding and a being a consultant or in an advisory role with Bristol-Myers Squibb.

CHICAGO – Combining two approved therapies – GM-CSF and ipilimumab – extended overall survival rates by 35% and resulted in fewer grade 3-5 adverse events when compared with ipilimumab alone in a randomized study of 245 patients with metastatic melanoma.

At 1 year, the overall survival rate in the combination therapy group was 69%, with a median follow-up of nearly 18 months. At 1 year, survival in the ipilimumab-only group was 53% with a median follow-up of nearly 13 months, Dr. F. Stephen Hodi, Jr. reported at the annual meeting of the American Society of Clinical Oncology.

This is the first phase II trial to look at ipilimumab (Yervoy, Bristol-Myers Squibb) and the granulocyte macrophage colony-stimulating factor (GM-CSF) sargramostim (Leukine, Sanofi) in combination in any cancer, said Dr. Hodi, the principal investigator for the trial, which was conducted by the ECOG-ACRIN Cancer Research Group (formerly the Eastern Cooperative Oncology Group) trial. In this study, ipilimumab was used at a dose of 10 mg/kg, which is higher than the FDA-approved dose of 3 mg/kg.

"We are waiting for the data to mature in ongoing studies examining the relative efficacy of 3 mg/kg and 10 mg/kg dosing," said Dr. Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston.

The results in the current trial are another indication of the impact that immunotherapy can have for patients with advanced melanoma. Since both GM-CSF and ipilimumab are commercially available, oncologists need to determine the best way to apply these findings in everyday practice. The next step will then be to define the role of GM-CSF in combination with other immune checkpoint targeting drugs, such as therapies that target the PD-1 and PD-L1 pathway, he said.

"We have been using GM-CSF in melanoma as a stand-alone therapy," Dr. Lynn M. Schuchter, the C. Willard Robinson Professor of Hematology-Oncology at the University of Pennsylvania, Philadelphia, and an expert on melanoma, said at a press conference where the study results were announced. "It will be interesting to see if payers will cover this (combination treatment)."

Ipilimumab targets CTLA-4, a protein that keeps immune T-cells in an inactive state. GM-CSF is a growth factor commonly used to boost white blood cell counts after chemotherapy or stem cell transplantation.

For this study, 245 patients were randomized to receive ipilimumab plus GM-CSF or ipilimumab alone. All study participants were in otherwise good health, with an ECOG performance status of 0-1 and adequate end-organ function, no autoimmune disease, and no prior use of CTLA-4 blockade or CD137 agonists. All had radiographically measurable metastatic melanoma, but with no CNS metastases, and had received up to one prior treatment over 4 weeks before starting in the trial.

The 123 patients randomized to the combination therapy were given sargramostim at 250 micrograms injected subcutaneously on day 1-14 of a 21 day cycle. For induction therapy, ipilimumab was given at a dose of 10 mg/kg intravenously once every 3 weeks for four cycles as induction therapy and once every 12 weeks as maintenance therapy. The 122 patients randomized to ipilimumab alone received the drug on the same schedule.

In both study arms, tumor shrinkage rates were comparable at 11% and 14%, and progression-free survival was similar at about 3 months. But the overall survival rate was longer in the combination treatment arm. One year after the start of therapy and with a median follow-up of 13.3 months, 69% of patients given the combination therapy and 53% of those who got ipilimumab alone were still alive, for a 35% lower risk of death with the combination therapy (hazard ratio, 0.64; P = .014).

Additionally, the combination treatment was associated with fewer serious side effects, compared with ipilimumab alone. The most significant differences were in lung and gastrointestinal toxicities.

Grade 3-5 adverse events occurred in 45% of patients given the combination therapy and in 57% given ipilimumab alone (p2 = 0.078). There were two possible treatment-related deaths in the combination arm (one colonic perforation and one cardiac arrest) and 7 possible treatment-related deaths in the ipilimumab-only arm: (two cases of multi-organ failure, two colonic perforations, one case of liver failure, and two cases of respiratory failure).

The research was supported in part by the National Cancer Institute (Cancer Therapy Evaluation Program), Sanofi, and Bristol-Myers Squibb. Dr. Hodi disclosed receiving research funding and a being a consultant or in an advisory role with Bristol-Myers Squibb.

CHICAGO – Combining two approved therapies – GM-CSF and ipilimumab – extended overall survival rates by 35% and resulted in fewer grade 3-5 adverse events when compared with ipilimumab alone in a randomized study of 245 patients with metastatic melanoma.

At 1 year, the overall survival rate in the combination therapy group was 69%, with a median follow-up of nearly 18 months. At 1 year, survival in the ipilimumab-only group was 53% with a median follow-up of nearly 13 months, Dr. F. Stephen Hodi, Jr. reported at the annual meeting of the American Society of Clinical Oncology.

This is the first phase II trial to look at ipilimumab (Yervoy, Bristol-Myers Squibb) and the granulocyte macrophage colony-stimulating factor (GM-CSF) sargramostim (Leukine, Sanofi) in combination in any cancer, said Dr. Hodi, the principal investigator for the trial, which was conducted by the ECOG-ACRIN Cancer Research Group (formerly the Eastern Cooperative Oncology Group) trial. In this study, ipilimumab was used at a dose of 10 mg/kg, which is higher than the FDA-approved dose of 3 mg/kg.

"We are waiting for the data to mature in ongoing studies examining the relative efficacy of 3 mg/kg and 10 mg/kg dosing," said Dr. Hodi, director of the melanoma center at Dana-Farber Cancer Institute in Boston.

The results in the current trial are another indication of the impact that immunotherapy can have for patients with advanced melanoma. Since both GM-CSF and ipilimumab are commercially available, oncologists need to determine the best way to apply these findings in everyday practice. The next step will then be to define the role of GM-CSF in combination with other immune checkpoint targeting drugs, such as therapies that target the PD-1 and PD-L1 pathway, he said.

"We have been using GM-CSF in melanoma as a stand-alone therapy," Dr. Lynn M. Schuchter, the C. Willard Robinson Professor of Hematology-Oncology at the University of Pennsylvania, Philadelphia, and an expert on melanoma, said at a press conference where the study results were announced. "It will be interesting to see if payers will cover this (combination treatment)."

Ipilimumab targets CTLA-4, a protein that keeps immune T-cells in an inactive state. GM-CSF is a growth factor commonly used to boost white blood cell counts after chemotherapy or stem cell transplantation.

For this study, 245 patients were randomized to receive ipilimumab plus GM-CSF or ipilimumab alone. All study participants were in otherwise good health, with an ECOG performance status of 0-1 and adequate end-organ function, no autoimmune disease, and no prior use of CTLA-4 blockade or CD137 agonists. All had radiographically measurable metastatic melanoma, but with no CNS metastases, and had received up to one prior treatment over 4 weeks before starting in the trial.

The 123 patients randomized to the combination therapy were given sargramostim at 250 micrograms injected subcutaneously on day 1-14 of a 21 day cycle. For induction therapy, ipilimumab was given at a dose of 10 mg/kg intravenously once every 3 weeks for four cycles as induction therapy and once every 12 weeks as maintenance therapy. The 122 patients randomized to ipilimumab alone received the drug on the same schedule.

In both study arms, tumor shrinkage rates were comparable at 11% and 14%, and progression-free survival was similar at about 3 months. But the overall survival rate was longer in the combination treatment arm. One year after the start of therapy and with a median follow-up of 13.3 months, 69% of patients given the combination therapy and 53% of those who got ipilimumab alone were still alive, for a 35% lower risk of death with the combination therapy (hazard ratio, 0.64; P = .014).

Additionally, the combination treatment was associated with fewer serious side effects, compared with ipilimumab alone. The most significant differences were in lung and gastrointestinal toxicities.

Grade 3-5 adverse events occurred in 45% of patients given the combination therapy and in 57% given ipilimumab alone (p2 = 0.078). There were two possible treatment-related deaths in the combination arm (one colonic perforation and one cardiac arrest) and 7 possible treatment-related deaths in the ipilimumab-only arm: (two cases of multi-organ failure, two colonic perforations, one case of liver failure, and two cases of respiratory failure).

The research was supported in part by the National Cancer Institute (Cancer Therapy Evaluation Program), Sanofi, and Bristol-Myers Squibb. Dr. Hodi disclosed receiving research funding and a being a consultant or in an advisory role with Bristol-Myers Squibb.

CHICAGO – With new targeted therapies and immunotherapies for metastatic melanoma, chemotherapy is now a thirdtier option for these patients, according to melanoma expert Dr. Lynn M. Schuchter, of the University of Pennsylvania, Philadelphia.

Dr. Schuchter discusses new practice-changing approaches in the treatment of melanoma in an interview at the annual meeting of the American Society of Clinical Oncology.

CHICAGO – With new targeted therapies and immunotherapies for metastatic melanoma, chemotherapy is now a thirdtier option for these patients, according to melanoma expert Dr. Lynn M. Schuchter, of the University of Pennsylvania, Philadelphia.

Dr. Schuchter discusses new practice-changing approaches in the treatment of melanoma in an interview at the annual meeting of the American Society of Clinical Oncology.

CHICAGO – With new targeted therapies and immunotherapies for metastatic melanoma, chemotherapy is now a thirdtier option for these patients, according to melanoma expert Dr. Lynn M. Schuchter, of the University of Pennsylvania, Philadelphia.

Dr. Schuchter discusses new practice-changing approaches in the treatment of melanoma in an interview at the annual meeting of the American Society of Clinical Oncology.

An oral three-drug regimen of aprepitant, a 5HT₃ antagonist, and dexamethasone is reasonable and necessary immediately before and within 48 hours after moderately emetogenic chemotherapy is administered to Medicare beneficiaries, the Centers for Medicare and Medicaid Services stated in a proposed decision memo.  

This regimen would be covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination: alemtuzumab, azacitidine, bendamustine, carboplatin, carmustine, cisplatin, clofarabine, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, lomustine, mechlorethamine, oxaliplatin, and streptozocin, according to the CMS. 

The proposal would expand coverage of the three-drug regimen to include its use with additional chemotherapy drugs that are not currently covered, including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cytarabine, daunorubicin, idarubicin, ifosfamide, irinotecan and oxaliplatin.

CMS defines moderately emetogenic chemotherapy as any anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC). 

According to the CMS, 70%-80% of all patients receiving chemotherapy experience nausea and vomiting. Chemotherapy induced emesis can impair quality of life, as well as cause dehydration, malnutrition, fatigue, confusion, electrolyte imbalance, esophageal tears and aspiration pneumonia. Further, poor control of the emesis can interrupt or force withdrawal from critical chemotherapy.

"We are mindful of the relatively minimal risks of the three-drug antiemetic regimen; the severe consequences that can occur if chemotherapy is delayed or halted altogether because of emesis; and the frequency with which new anticancer chemotherapeutic agents appear.  We also recognize that the available classification schemes for chemotherapy emetogenicity may evolve as evidence continues to be developed on this problem," CMS officials stated in their proposed decision memo.

They also proposed that Medicare Administrative Contractors be allowed to determine coverage for an oral three-drug antiemesis regimen of aprepitant, a 5HT₃ antagonist and dexamethasone with other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic in at least two of three guidelines from NCCN, ASCO, and ESMO)/MASCC.

The CMS is seeking comments on the proposal, especially in regard to whether the term “NK-1 antagonists” should be used in its coverage manual. Aprepitant is currently the sole NK-1 antagonist component of the three drug antiemetic regimen.  The CMS will respond to public comments in a final decision memorandum.

An oral three-drug regimen of aprepitant, a 5HT₃ antagonist, and dexamethasone is reasonable and necessary immediately before and within 48 hours after moderately emetogenic chemotherapy is administered to Medicare beneficiaries, the Centers for Medicare and Medicaid Services stated in a proposed decision memo.  

This regimen would be covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination: alemtuzumab, azacitidine, bendamustine, carboplatin, carmustine, cisplatin, clofarabine, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, lomustine, mechlorethamine, oxaliplatin, and streptozocin, according to the CMS. 

The proposal would expand coverage of the three-drug regimen to include its use with additional chemotherapy drugs that are not currently covered, including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cytarabine, daunorubicin, idarubicin, ifosfamide, irinotecan and oxaliplatin.

CMS defines moderately emetogenic chemotherapy as any anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC). 

According to the CMS, 70%-80% of all patients receiving chemotherapy experience nausea and vomiting. Chemotherapy induced emesis can impair quality of life, as well as cause dehydration, malnutrition, fatigue, confusion, electrolyte imbalance, esophageal tears and aspiration pneumonia. Further, poor control of the emesis can interrupt or force withdrawal from critical chemotherapy.

"We are mindful of the relatively minimal risks of the three-drug antiemetic regimen; the severe consequences that can occur if chemotherapy is delayed or halted altogether because of emesis; and the frequency with which new anticancer chemotherapeutic agents appear.  We also recognize that the available classification schemes for chemotherapy emetogenicity may evolve as evidence continues to be developed on this problem," CMS officials stated in their proposed decision memo.

They also proposed that Medicare Administrative Contractors be allowed to determine coverage for an oral three-drug antiemesis regimen of aprepitant, a 5HT₃ antagonist and dexamethasone with other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic in at least two of three guidelines from NCCN, ASCO, and ESMO)/MASCC.

The CMS is seeking comments on the proposal, especially in regard to whether the term “NK-1 antagonists” should be used in its coverage manual. Aprepitant is currently the sole NK-1 antagonist component of the three drug antiemetic regimen.  The CMS will respond to public comments in a final decision memorandum.

An oral three-drug regimen of aprepitant, a 5HT₃ antagonist, and dexamethasone is reasonable and necessary immediately before and within 48 hours after moderately emetogenic chemotherapy is administered to Medicare beneficiaries, the Centers for Medicare and Medicaid Services stated in a proposed decision memo.  

This regimen would be covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination: alemtuzumab, azacitidine, bendamustine, carboplatin, carmustine, cisplatin, clofarabine, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, lomustine, mechlorethamine, oxaliplatin, and streptozocin, according to the CMS. 

The proposal would expand coverage of the three-drug regimen to include its use with additional chemotherapy drugs that are not currently covered, including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cytarabine, daunorubicin, idarubicin, ifosfamide, irinotecan and oxaliplatin.

CMS defines moderately emetogenic chemotherapy as any anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC). 

According to the CMS, 70%-80% of all patients receiving chemotherapy experience nausea and vomiting. Chemotherapy induced emesis can impair quality of life, as well as cause dehydration, malnutrition, fatigue, confusion, electrolyte imbalance, esophageal tears and aspiration pneumonia. Further, poor control of the emesis can interrupt or force withdrawal from critical chemotherapy.

"We are mindful of the relatively minimal risks of the three-drug antiemetic regimen; the severe consequences that can occur if chemotherapy is delayed or halted altogether because of emesis; and the frequency with which new anticancer chemotherapeutic agents appear.  We also recognize that the available classification schemes for chemotherapy emetogenicity may evolve as evidence continues to be developed on this problem," CMS officials stated in their proposed decision memo.

They also proposed that Medicare Administrative Contractors be allowed to determine coverage for an oral three-drug antiemesis regimen of aprepitant, a 5HT₃ antagonist and dexamethasone with other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic in at least two of three guidelines from NCCN, ASCO, and ESMO)/MASCC.

The CMS is seeking comments on the proposal, especially in regard to whether the term “NK-1 antagonists” should be used in its coverage manual. Aprepitant is currently the sole NK-1 antagonist component of the three drug antiemetic regimen.  The CMS will respond to public comments in a final decision memorandum.

A radioactive diagnostic imaging agent called Lymphoseek (technetium Tc 99m tilmanocept) Injection has been approved for locating lymph nodes in patients who have breast cancer or melanoma and are undergoing surgery to remove tumor-draining lymph nodes, the Food and Drug Administration announced.

Lymphoseek is the first new drug for lymph-node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph-node mapping include sulfur colloid and isosulfan blue.

"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity," said Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research.

Lymphoseek is marketed by Navidea Biopharmaceuticals. The manufacturer’s website notes that the ability to rapidly locate and biopsy sentinel nodes enables surgical management to be tailored specifically to each patient’s burden of disease.

In two clinical trials, 332 patients with melanoma or breast cancer were injected with Lymphoseek and blue dye. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and Lymphoseek. The combination of Lymphoseek and blue dye localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials were pain and irritation at the injection site.

According to the manufacturer, a clinical trial involving patients with head and neck cancer is completing enrollment and is expected to be the subject of a future New Drug Application amendment. An initial Marketing Authorization Application filing in the European Union is anticipated by the end of 2012.

[email protected]

A radioactive diagnostic imaging agent called Lymphoseek (technetium Tc 99m tilmanocept) Injection has been approved for locating lymph nodes in patients who have breast cancer or melanoma and are undergoing surgery to remove tumor-draining lymph nodes, the Food and Drug Administration announced.

Lymphoseek is the first new drug for lymph-node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph-node mapping include sulfur colloid and isosulfan blue.

"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity," said Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research.

Lymphoseek is marketed by Navidea Biopharmaceuticals. The manufacturer’s website notes that the ability to rapidly locate and biopsy sentinel nodes enables surgical management to be tailored specifically to each patient’s burden of disease.

In two clinical trials, 332 patients with melanoma or breast cancer were injected with Lymphoseek and blue dye. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and Lymphoseek. The combination of Lymphoseek and blue dye localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials were pain and irritation at the injection site.

According to the manufacturer, a clinical trial involving patients with head and neck cancer is completing enrollment and is expected to be the subject of a future New Drug Application amendment. An initial Marketing Authorization Application filing in the European Union is anticipated by the end of 2012.

[email protected]

A radioactive diagnostic imaging agent called Lymphoseek (technetium Tc 99m tilmanocept) Injection has been approved for locating lymph nodes in patients who have breast cancer or melanoma and are undergoing surgery to remove tumor-draining lymph nodes, the Food and Drug Administration announced.

Lymphoseek is the first new drug for lymph-node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph-node mapping include sulfur colloid and isosulfan blue.

"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity," said Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research.

Lymphoseek is marketed by Navidea Biopharmaceuticals. The manufacturer’s website notes that the ability to rapidly locate and biopsy sentinel nodes enables surgical management to be tailored specifically to each patient’s burden of disease.

In two clinical trials, 332 patients with melanoma or breast cancer were injected with Lymphoseek and blue dye. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and Lymphoseek. The combination of Lymphoseek and blue dye localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials were pain and irritation at the injection site.

According to the manufacturer, a clinical trial involving patients with head and neck cancer is completing enrollment and is expected to be the subject of a future New Drug Application amendment. An initial Marketing Authorization Application filing in the European Union is anticipated by the end of 2012.

[email protected]

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"

Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.

The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.

Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.

Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.

Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.

Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.

Pomalidomide is marketed by Celgene.

[email protected]

On Twitter @maryjodales

An unapproved medicine is being distributed as bevacizumab by Medical Device King, a U.S.-based company also known as Pharmalogical and Taranis Medical, the Food and Drug Administration has announced.

Tests have confirmed that there is no active ingredient in at least one batch of the counterfeit version of Roche’s Altuzan 400 mg/16 mL, an injectable version of bevacizumab that is not approved in the United States.

Avastin (Genentech) is the only FDA-approved version of bevacizumab for sale in the United States.

The FDA is advising practices to stop using any medical products that may have been obtained from Medical Device King, Pharmalogical, and Taranis Medical and to contact FDA’s Office of Criminal Investigations to arrange for the collection of these products.

To report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources, contact the FDA’s Office of Criminal Investigations at 800-551-3989, www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or via e-mail to [email protected].

[email protected]

An unapproved medicine is being distributed as bevacizumab by Medical Device King, a U.S.-based company also known as Pharmalogical and Taranis Medical, the Food and Drug Administration has announced.

Tests have confirmed that there is no active ingredient in at least one batch of the counterfeit version of Roche’s Altuzan 400 mg/16 mL, an injectable version of bevacizumab that is not approved in the United States.

Avastin (Genentech) is the only FDA-approved version of bevacizumab for sale in the United States.

The FDA is advising practices to stop using any medical products that may have been obtained from Medical Device King, Pharmalogical, and Taranis Medical and to contact FDA’s Office of Criminal Investigations to arrange for the collection of these products.

To report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources, contact the FDA’s Office of Criminal Investigations at 800-551-3989, www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or via e-mail to [email protected].

[email protected]

An unapproved medicine is being distributed as bevacizumab by Medical Device King, a U.S.-based company also known as Pharmalogical and Taranis Medical, the Food and Drug Administration has announced.

Tests have confirmed that there is no active ingredient in at least one batch of the counterfeit version of Roche’s Altuzan 400 mg/16 mL, an injectable version of bevacizumab that is not approved in the United States.

Avastin (Genentech) is the only FDA-approved version of bevacizumab for sale in the United States.

The FDA is advising practices to stop using any medical products that may have been obtained from Medical Device King, Pharmalogical, and Taranis Medical and to contact FDA’s Office of Criminal Investigations to arrange for the collection of these products.

To report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources, contact the FDA’s Office of Criminal Investigations at 800-551-3989, www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or via e-mail to [email protected].

[email protected]

Imatinib has been approved to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia, the Food and Drug Administration announced Jan. 25.

Imatinib (Gleevec), a tyrosine kinase inhibitor, should be used in combination with chemotherapy to treat children with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

"Today’s approval is the result of continuous interactions among the FDA, the Children’s Oncology Group and the National Cancer Institute to provide new and better treatments to American children with cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement announcing the approval.

Imatinib’s safety and effectiveness for this new indication were established in a clinical trial conducted by the Children’s Oncology Group and sponsored by the National Cancer Institute. The trial enrolled children and young adults 1 year and older with high-risk ALL, defined having a greater than 45% chance of causing complications within 5 years of treatment.

There were a total of 92 patients with Ph+ ALL who were divided into five treatment groups, with each successive group receiving a greater duration of imatinib treatment in combination with chemotherapy. Of the 50 Ph+ ALL patients who received imatinib for the longest duration, 70% had event-free survival with no relapses or deaths within 4 years. Patient deaths declined with increasing duration of imatinib treatment in combination with chemotherapy.

The most common side effects observed in the study included decreased levels of neutrophils, decreased levels of blood platelets, liver toxicity, and infection.

Imatinib was granted accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia who had failed interferon-alpha therapy. Imatinib was subsequently approved to treat several conditions, including newly diagnosed Ph+ chronic myelogenous leukemia in children and in adults with Kit (CD117)-positive gastrointestinal stromal tumors that have been surgically removed.

[email protected]

Imatinib has been approved to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia, the Food and Drug Administration announced Jan. 25.

Imatinib (Gleevec), a tyrosine kinase inhibitor, should be used in combination with chemotherapy to treat children with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

"Today’s approval is the result of continuous interactions among the FDA, the Children’s Oncology Group and the National Cancer Institute to provide new and better treatments to American children with cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement announcing the approval.

Imatinib’s safety and effectiveness for this new indication were established in a clinical trial conducted by the Children’s Oncology Group and sponsored by the National Cancer Institute. The trial enrolled children and young adults 1 year and older with high-risk ALL, defined having a greater than 45% chance of causing complications within 5 years of treatment.

There were a total of 92 patients with Ph+ ALL who were divided into five treatment groups, with each successive group receiving a greater duration of imatinib treatment in combination with chemotherapy. Of the 50 Ph+ ALL patients who received imatinib for the longest duration, 70% had event-free survival with no relapses or deaths within 4 years. Patient deaths declined with increasing duration of imatinib treatment in combination with chemotherapy.

The most common side effects observed in the study included decreased levels of neutrophils, decreased levels of blood platelets, liver toxicity, and infection.

Imatinib was granted accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia who had failed interferon-alpha therapy. Imatinib was subsequently approved to treat several conditions, including newly diagnosed Ph+ chronic myelogenous leukemia in children and in adults with Kit (CD117)-positive gastrointestinal stromal tumors that have been surgically removed.

[email protected]

Imatinib has been approved to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia, the Food and Drug Administration announced Jan. 25.

Imatinib (Gleevec), a tyrosine kinase inhibitor, should be used in combination with chemotherapy to treat children with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

"Today’s approval is the result of continuous interactions among the FDA, the Children’s Oncology Group and the National Cancer Institute to provide new and better treatments to American children with cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement announcing the approval.

Imatinib’s safety and effectiveness for this new indication were established in a clinical trial conducted by the Children’s Oncology Group and sponsored by the National Cancer Institute. The trial enrolled children and young adults 1 year and older with high-risk ALL, defined having a greater than 45% chance of causing complications within 5 years of treatment.

There were a total of 92 patients with Ph+ ALL who were divided into five treatment groups, with each successive group receiving a greater duration of imatinib treatment in combination with chemotherapy. Of the 50 Ph+ ALL patients who received imatinib for the longest duration, 70% had event-free survival with no relapses or deaths within 4 years. Patient deaths declined with increasing duration of imatinib treatment in combination with chemotherapy.

The most common side effects observed in the study included decreased levels of neutrophils, decreased levels of blood platelets, liver toxicity, and infection.

Imatinib was granted accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia who had failed interferon-alpha therapy. Imatinib was subsequently approved to treat several conditions, including newly diagnosed Ph+ chronic myelogenous leukemia in children and in adults with Kit (CD117)-positive gastrointestinal stromal tumors that have been surgically removed.

[email protected]

Low-dose CT scans were endorsed for lung cancer screening in select high-risk individuals in guidelines from the American Cancer Society.

"Clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about lung cancer screening with patients aged 55 years to 74 years who have at least a 30–pack-year smoking history, currently smoke, or have quit within the past 15 years, and who are in relatively good health," wrote Dr. Richard Wender and the members of the guidelines committee in an article published online in CA: A Cancer Journal for Clinicians (doi: 10.3322/caac.21172).

The recommendations are centered on the eligibility criteria used in the NLST (National Lung Screening Trial). Because of the uncertainty regarding the balance of benefits and harms, low-dose CT screening is not recommended for individuals at younger or older ages, with less lifetime exposure to tobacco smoke, and with sufficiently severe lung damage to require oxygen. The guideline writers acknowledge that clinicians will need to rely on their best judgment in cases when risk seems to approximate or exceed the NLST eligibility criteria in one category but not in another.

Since few government or private insurance programs provide coverage for the initial low-dose CT for lung cancer screening, "clinicians who decide to offer screening bear the responsibility of helping patients determine if they will have to pay for the initial test themselves and to help the patient know how much they will have to pay," according to the guideline writers. "In light of the firm evidence that screening high-risk individuals can substantially reduce death rates from lung cancer, both private and public health care insurers should expand coverage to include the cost of annual (low-dose CT) screening for lung cancer in appropriate high-risk individuals."

The "meaningful use" criteria for electronic health records under the recent HITECH (Health Information Technology for Economic and Clinical Health) Act are likely to improve identification of patients eligible for this screening as clinicians are required to determine the smoking status of more than 50% of their patients who are aged 13 years or older and to track the percentage of patients aged 10 years and older who are current smokers, according to Dr. Wender, chair of the department of family and community medicine, Jefferson Medical College, Philadelphia, and the other guideline writers.

While low-dose CT screening has been shown to substantially reduce the risk of dying of lung cancer, the technology will not detect all lung cancers or all lung cancers in early enough stages to avoid death from lung cancer. Further, a false-positive finding runs the risk of prompting an invasive procedure for incidental findings. The guidelines also warn that current smokers should not view screening as a substitute for smoking cessation. Counseling is recommended for current smokers, and all patients eligible for annual screening should make the decision only if they are willing to accept the risks and costs of annual screening until they reach age 74 years.

The guidelines also note that chest x-rays should not be used for lung cancer screening.

Wherever possible, screening should be performed as part of an organized program at an institution with expertise in low-dose CT screening and a multidisciplinary team skilled in the evaluation, diagnosis, and treatment of abnormal lung lesions. When those options are available but patients strongly wish to be screened, they should be referred to a center that performs a reasonably high volume of lung CT scans, diagnostic tests, and lung cancer surgeries. Otherwise, "the risks of cancer screening may be substantially higher than the observed risks associated with screening in the NLST, and screening is not recommended."

Multiple members of the guideline committee had financial disclosures related to drug manufacturers. The single committee member with ties to a device manufacturer declared his work was not directly related to the article.

[email protected]

On Twitter @maryjodales

Low-dose CT scans were endorsed for lung cancer screening in select high-risk individuals in guidelines from the American Cancer Society.

"Clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about lung cancer screening with patients aged 55 years to 74 years who have at least a 30–pack-year smoking history, currently smoke, or have quit within the past 15 years, and who are in relatively good health," wrote Dr. Richard Wender and the members of the guidelines committee in an article published online in CA: A Cancer Journal for Clinicians (doi: 10.3322/caac.21172).

The recommendations are centered on the eligibility criteria used in the NLST (National Lung Screening Trial). Because of the uncertainty regarding the balance of benefits and harms, low-dose CT screening is not recommended for individuals at younger or older ages, with less lifetime exposure to tobacco smoke, and with sufficiently severe lung damage to require oxygen. The guideline writers acknowledge that clinicians will need to rely on their best judgment in cases when risk seems to approximate or exceed the NLST eligibility criteria in one category but not in another.

Since few government or private insurance programs provide coverage for the initial low-dose CT for lung cancer screening, "clinicians who decide to offer screening bear the responsibility of helping patients determine if they will have to pay for the initial test themselves and to help the patient know how much they will have to pay," according to the guideline writers. "In light of the firm evidence that screening high-risk individuals can substantially reduce death rates from lung cancer, both private and public health care insurers should expand coverage to include the cost of annual (low-dose CT) screening for lung cancer in appropriate high-risk individuals."

The "meaningful use" criteria for electronic health records under the recent HITECH (Health Information Technology for Economic and Clinical Health) Act are likely to improve identification of patients eligible for this screening as clinicians are required to determine the smoking status of more than 50% of their patients who are aged 13 years or older and to track the percentage of patients aged 10 years and older who are current smokers, according to Dr. Wender, chair of the department of family and community medicine, Jefferson Medical College, Philadelphia, and the other guideline writers.

While low-dose CT screening has been shown to substantially reduce the risk of dying of lung cancer, the technology will not detect all lung cancers or all lung cancers in early enough stages to avoid death from lung cancer. Further, a false-positive finding runs the risk of prompting an invasive procedure for incidental findings. The guidelines also warn that current smokers should not view screening as a substitute for smoking cessation. Counseling is recommended for current smokers, and all patients eligible for annual screening should make the decision only if they are willing to accept the risks and costs of annual screening until they reach age 74 years.

The guidelines also note that chest x-rays should not be used for lung cancer screening.

Wherever possible, screening should be performed as part of an organized program at an institution with expertise in low-dose CT screening and a multidisciplinary team skilled in the evaluation, diagnosis, and treatment of abnormal lung lesions. When those options are available but patients strongly wish to be screened, they should be referred to a center that performs a reasonably high volume of lung CT scans, diagnostic tests, and lung cancer surgeries. Otherwise, "the risks of cancer screening may be substantially higher than the observed risks associated with screening in the NLST, and screening is not recommended."

Multiple members of the guideline committee had financial disclosures related to drug manufacturers. The single committee member with ties to a device manufacturer declared his work was not directly related to the article.

[email protected]

On Twitter @maryjodales

Low-dose CT scans were endorsed for lung cancer screening in select high-risk individuals in guidelines from the American Cancer Society.

"Clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about lung cancer screening with patients aged 55 years to 74 years who have at least a 30–pack-year smoking history, currently smoke, or have quit within the past 15 years, and who are in relatively good health," wrote Dr. Richard Wender and the members of the guidelines committee in an article published online in CA: A Cancer Journal for Clinicians (doi: 10.3322/caac.21172).

The recommendations are centered on the eligibility criteria used in the NLST (National Lung Screening Trial). Because of the uncertainty regarding the balance of benefits and harms, low-dose CT screening is not recommended for individuals at younger or older ages, with less lifetime exposure to tobacco smoke, and with sufficiently severe lung damage to require oxygen. The guideline writers acknowledge that clinicians will need to rely on their best judgment in cases when risk seems to approximate or exceed the NLST eligibility criteria in one category but not in another.

Since few government or private insurance programs provide coverage for the initial low-dose CT for lung cancer screening, "clinicians who decide to offer screening bear the responsibility of helping patients determine if they will have to pay for the initial test themselves and to help the patient know how much they will have to pay," according to the guideline writers. "In light of the firm evidence that screening high-risk individuals can substantially reduce death rates from lung cancer, both private and public health care insurers should expand coverage to include the cost of annual (low-dose CT) screening for lung cancer in appropriate high-risk individuals."

The "meaningful use" criteria for electronic health records under the recent HITECH (Health Information Technology for Economic and Clinical Health) Act are likely to improve identification of patients eligible for this screening as clinicians are required to determine the smoking status of more than 50% of their patients who are aged 13 years or older and to track the percentage of patients aged 10 years and older who are current smokers, according to Dr. Wender, chair of the department of family and community medicine, Jefferson Medical College, Philadelphia, and the other guideline writers.

While low-dose CT screening has been shown to substantially reduce the risk of dying of lung cancer, the technology will not detect all lung cancers or all lung cancers in early enough stages to avoid death from lung cancer. Further, a false-positive finding runs the risk of prompting an invasive procedure for incidental findings. The guidelines also warn that current smokers should not view screening as a substitute for smoking cessation. Counseling is recommended for current smokers, and all patients eligible for annual screening should make the decision only if they are willing to accept the risks and costs of annual screening until they reach age 74 years.

The guidelines also note that chest x-rays should not be used for lung cancer screening.

Wherever possible, screening should be performed as part of an organized program at an institution with expertise in low-dose CT screening and a multidisciplinary team skilled in the evaluation, diagnosis, and treatment of abnormal lung lesions. When those options are available but patients strongly wish to be screened, they should be referred to a center that performs a reasonably high volume of lung CT scans, diagnostic tests, and lung cancer surgeries. Otherwise, "the risks of cancer screening may be substantially higher than the observed risks associated with screening in the NLST, and screening is not recommended."

Multiple members of the guideline committee had financial disclosures related to drug manufacturers. The single committee member with ties to a device manufacturer declared his work was not directly related to the article.

[email protected]

On Twitter @maryjodales

The Food and Drug Administration has approved the Skyla intrauterine device.

The device is the first new IUD to be brought to the U.S. market in 12 years, Dr. Pamela A. Cyrus, vice president and head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals, the device’s manufacturer, said in a press release.

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of Feb. 11, according to the manufacturer.

Skyla "is more than 99% effective at preventing pregnancy," Dr. Anita L. Nelson, professor of obstetrics and gynecology at Harbor–UCLA Medical Center, Torrance, Calif., said in the Bayer statement. "Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years."

The approval of Skyla is supported by data from a phase III trial of 1,432 women aged 18-35 years who received the device. Nearly 40% (556 women) were nulliparous. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the United States, and Canada. The trial excluded women less than 6 weeks post partum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections.

The pregnancy rate using the Pearl Index calculated based on 28-day equivalent exposure cycles was the primary efficacy endpoint used to assess contraceptive reliability. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period.

The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 22% discontinued the study treatment because of an adverse event. Adverse reactions occurring in at least 5% of users were vulvovaginitis (20%), abdominal/pelvic pain (19%), acne/seborrhea (15%), ovarian cyst (13%), headache (12%), dysmenorrhea (9%), breast pain/discomfort (9%), increased bleeding (8%), and nausea (6%).

The Skyla T-body measures 28 mm x 30 mm, and the outer diameter of the placement tube is 3.8 mm. Women can become pregnant as soon as Skyla is removed. Based on study data, 77% of women who wanted to conceive became pregnant sometime in the first year after Skyla was removed.

[email protected]

The Food and Drug Administration has approved the Skyla intrauterine device.

The device is the first new IUD to be brought to the U.S. market in 12 years, Dr. Pamela A. Cyrus, vice president and head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals, the device’s manufacturer, said in a press release.

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of Feb. 11, according to the manufacturer.

Skyla "is more than 99% effective at preventing pregnancy," Dr. Anita L. Nelson, professor of obstetrics and gynecology at Harbor–UCLA Medical Center, Torrance, Calif., said in the Bayer statement. "Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years."

The approval of Skyla is supported by data from a phase III trial of 1,432 women aged 18-35 years who received the device. Nearly 40% (556 women) were nulliparous. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the United States, and Canada. The trial excluded women less than 6 weeks post partum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections.

The pregnancy rate using the Pearl Index calculated based on 28-day equivalent exposure cycles was the primary efficacy endpoint used to assess contraceptive reliability. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period.

The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 22% discontinued the study treatment because of an adverse event. Adverse reactions occurring in at least 5% of users were vulvovaginitis (20%), abdominal/pelvic pain (19%), acne/seborrhea (15%), ovarian cyst (13%), headache (12%), dysmenorrhea (9%), breast pain/discomfort (9%), increased bleeding (8%), and nausea (6%).

The Skyla T-body measures 28 mm x 30 mm, and the outer diameter of the placement tube is 3.8 mm. Women can become pregnant as soon as Skyla is removed. Based on study data, 77% of women who wanted to conceive became pregnant sometime in the first year after Skyla was removed.

[email protected]

The Food and Drug Administration has approved the Skyla intrauterine device.

The device is the first new IUD to be brought to the U.S. market in 12 years, Dr. Pamela A. Cyrus, vice president and head of U.S. medical affairs for Bayer HealthCare Pharmaceuticals, the device’s manufacturer, said in a press release.

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of Feb. 11, according to the manufacturer.

Skyla "is more than 99% effective at preventing pregnancy," Dr. Anita L. Nelson, professor of obstetrics and gynecology at Harbor–UCLA Medical Center, Torrance, Calif., said in the Bayer statement. "Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years."

The approval of Skyla is supported by data from a phase III trial of 1,432 women aged 18-35 years who received the device. Nearly 40% (556 women) were nulliparous. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the United States, and Canada. The trial excluded women less than 6 weeks post partum, those with a history of ectopic pregnancy, those with clinically significant ovarian cysts, and those with HIV or otherwise at high risk for sexually transmitted infections.

The pregnancy rate using the Pearl Index calculated based on 28-day equivalent exposure cycles was the primary efficacy endpoint used to assess contraceptive reliability. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the 3-year treatment period.

The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 22% discontinued the study treatment because of an adverse event. Adverse reactions occurring in at least 5% of users were vulvovaginitis (20%), abdominal/pelvic pain (19%), acne/seborrhea (15%), ovarian cyst (13%), headache (12%), dysmenorrhea (9%), breast pain/discomfort (9%), increased bleeding (8%), and nausea (6%).

The Skyla T-body measures 28 mm x 30 mm, and the outer diameter of the placement tube is 3.8 mm. Women can become pregnant as soon as Skyla is removed. Based on study data, 77% of women who wanted to conceive became pregnant sometime in the first year after Skyla was removed.

[email protected]