FDA/CDC

The U.S. Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer.

The adenovirus vector based gene therapy is indicated for adults with high-risk non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.

Patients with BCG-unresponsive disease “have historically had limited treatment options other than bladder removal surgery. The approval of Adstiladrin is therefore a significant advance in the current treatment landscape and provides a novel treatment option,” Steven Boorjian, MD, a Mayo Clinic urologist and lead investigator on that agent’s approval trial, said in a press release Dec. 16 from gene therapy developer Ferring Pharmaceuticals.

Nadofaragene firadenovec is instilled into the bladder via urinary catheter once every 3 months for up to a year. The adenovirus vector enters the cells of the bladder wall, releasing a gene that directs the cells to secrete high quantities of interferon alfa-2b, a naturally occurring cancer-fighting protein.

Approval was based on a multicenter clinical study that included 98 evaluable patients with high-risk, BCG-unresponsive disease. Overall, 51% achieved a complete response with a disappearance of all signs of cancer on cystoscopy, biopsied tissue, and urine. The median duration of response was 9.7 months. Overall, 46% of responding patients remained in complete response for at least 1 year.

The most common adverse events were instillation site discharge (33%), fatigue (24%), bladder spasm (20%), micturition urgency (19%), and hematuria (17%). The discontinuation rate due to adverse events was 1.9%.

Ferring expects the gene therapy to be commercially available in the United States in the second half of 2023.

The cost of the gene therapy has not yet been announced, but a cost effectiveness analysis from the Institute for Clinical and Economic Review, published last year, put the range for the annual cost between $158,600 and $262,000.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer.

The adenovirus vector based gene therapy is indicated for adults with high-risk non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.

Patients with BCG-unresponsive disease “have historically had limited treatment options other than bladder removal surgery. The approval of Adstiladrin is therefore a significant advance in the current treatment landscape and provides a novel treatment option,” Steven Boorjian, MD, a Mayo Clinic urologist and lead investigator on that agent’s approval trial, said in a press release Dec. 16 from gene therapy developer Ferring Pharmaceuticals.

Nadofaragene firadenovec is instilled into the bladder via urinary catheter once every 3 months for up to a year. The adenovirus vector enters the cells of the bladder wall, releasing a gene that directs the cells to secrete high quantities of interferon alfa-2b, a naturally occurring cancer-fighting protein.

Approval was based on a multicenter clinical study that included 98 evaluable patients with high-risk, BCG-unresponsive disease. Overall, 51% achieved a complete response with a disappearance of all signs of cancer on cystoscopy, biopsied tissue, and urine. The median duration of response was 9.7 months. Overall, 46% of responding patients remained in complete response for at least 1 year.

The most common adverse events were instillation site discharge (33%), fatigue (24%), bladder spasm (20%), micturition urgency (19%), and hematuria (17%). The discontinuation rate due to adverse events was 1.9%.

Ferring expects the gene therapy to be commercially available in the United States in the second half of 2023.

The cost of the gene therapy has not yet been announced, but a cost effectiveness analysis from the Institute for Clinical and Economic Review, published last year, put the range for the annual cost between $158,600 and $262,000.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer.

The adenovirus vector based gene therapy is indicated for adults with high-risk non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.

Patients with BCG-unresponsive disease “have historically had limited treatment options other than bladder removal surgery. The approval of Adstiladrin is therefore a significant advance in the current treatment landscape and provides a novel treatment option,” Steven Boorjian, MD, a Mayo Clinic urologist and lead investigator on that agent’s approval trial, said in a press release Dec. 16 from gene therapy developer Ferring Pharmaceuticals.

Nadofaragene firadenovec is instilled into the bladder via urinary catheter once every 3 months for up to a year. The adenovirus vector enters the cells of the bladder wall, releasing a gene that directs the cells to secrete high quantities of interferon alfa-2b, a naturally occurring cancer-fighting protein.

Approval was based on a multicenter clinical study that included 98 evaluable patients with high-risk, BCG-unresponsive disease. Overall, 51% achieved a complete response with a disappearance of all signs of cancer on cystoscopy, biopsied tissue, and urine. The median duration of response was 9.7 months. Overall, 46% of responding patients remained in complete response for at least 1 year.

The most common adverse events were instillation site discharge (33%), fatigue (24%), bladder spasm (20%), micturition urgency (19%), and hematuria (17%). The discontinuation rate due to adverse events was 1.9%.

Ferring expects the gene therapy to be commercially available in the United States in the second half of 2023.

The cost of the gene therapy has not yet been announced, but a cost effectiveness analysis from the Institute for Clinical and Economic Review, published last year, put the range for the annual cost between $158,600 and $262,000.

A version of this article first appeared on Medscape.com.

The U.S. Centers for Disease Control and Prevention has issued extended growth charts to help doctors and researchers better understand patterns of development for the most overweight children and adolescents.

In 2017-2018, more than 4.5 million U.S. youth met the criteria for severe obesity – defined as 120% of the 95th percentile, or 35 kg/m² or greater – according to the CDC.

The new growth charts will not replace the current charts but extend beyond the 97th percentile for body mass index. Formerly, data were extrapolated for anything over the 95th percentile based on evidence from 1963 to 1980, when obesity rates were lower.

The extended growth charts are based on data collected between 1988 and 2015 from young children and adolescents with obesity.

Experts said the expanded charts will allow researchers and clinicians to track the effects of interventions for obesity whether they involve an increase in physical activity, a decrease in consumption, or other interventions. The corresponding z-score charts also are provided.

Physicians should still use the CDC’s BMI-for-age growth charts from 2000 for pediatric patients with BMIs under the 95th percentile. The agency said it does not intend to update those charts.

The definitions of overweight, obesity, and severe obesity remain unchanged.
 

The U.S. Centers for Disease Control and Prevention has issued extended growth charts to help doctors and researchers better understand patterns of development for the most overweight children and adolescents.

In 2017-2018, more than 4.5 million U.S. youth met the criteria for severe obesity – defined as 120% of the 95th percentile, or 35 kg/m² or greater – according to the CDC.

The new growth charts will not replace the current charts but extend beyond the 97th percentile for body mass index. Formerly, data were extrapolated for anything over the 95th percentile based on evidence from 1963 to 1980, when obesity rates were lower.

The extended growth charts are based on data collected between 1988 and 2015 from young children and adolescents with obesity.

Experts said the expanded charts will allow researchers and clinicians to track the effects of interventions for obesity whether they involve an increase in physical activity, a decrease in consumption, or other interventions. The corresponding z-score charts also are provided.

Physicians should still use the CDC’s BMI-for-age growth charts from 2000 for pediatric patients with BMIs under the 95th percentile. The agency said it does not intend to update those charts.

The definitions of overweight, obesity, and severe obesity remain unchanged.
 

The U.S. Centers for Disease Control and Prevention has issued extended growth charts to help doctors and researchers better understand patterns of development for the most overweight children and adolescents.

In 2017-2018, more than 4.5 million U.S. youth met the criteria for severe obesity – defined as 120% of the 95th percentile, or 35 kg/m² or greater – according to the CDC.

The new growth charts will not replace the current charts but extend beyond the 97th percentile for body mass index. Formerly, data were extrapolated for anything over the 95th percentile based on evidence from 1963 to 1980, when obesity rates were lower.

The extended growth charts are based on data collected between 1988 and 2015 from young children and adolescents with obesity.

Experts said the expanded charts will allow researchers and clinicians to track the effects of interventions for obesity whether they involve an increase in physical activity, a decrease in consumption, or other interventions. The corresponding z-score charts also are provided.

Physicians should still use the CDC’s BMI-for-age growth charts from 2000 for pediatric patients with BMIs under the 95th percentile. The agency said it does not intend to update those charts.

The definitions of overweight, obesity, and severe obesity remain unchanged.
 

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in the United States, according to a press release from manufacturer Fresenius Kabi.

Idacio is a citrate-free, low-concentration formulation of adalimumab and is now approved for use for all but three of the indications that currently apply to the reference adalimumab product (Humira): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis in adults, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years or older, ulcerative colitis in adults, and plaque psoriasis in adults. It does not apply to Humira’s indications for hidradenitis suppurativa, uveitis, or ulcerative colitis in pediatric patients aged 5 years and older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Idacio is the eighth adalimumab biosimilar to be approved in the United States. Its approval was based on evidence of a similar profile of pharmacokinetics, safety, efficacy, and immunogenicity to Humira.

Idacio was first launched in 2019 and has been marketed in more than 37 countries worldwide, according to Fresenius Kabi. The U.S. launch is scheduled for July, and Idacio will be available as a self-administered prefilled syringe or prefilled pen.

A version of this article first appeared on Medscape.com.

A panel of advisers to the Food and Drug Administration has recommended against approval of omecamtiv mecarbil (Cytokinetics) for the treatment of heart failure with reduced ejection fraction (HFrEF).

Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA Cardiovascular and Renal Drugs Advisory Committee on Dec. 13 voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF.

Those who voted in favor of the drug cited the clinical benefit (albeit small) and good safety profile of the drug as well as the unmet need for new treatments.

C. Noel Bairey Merz, MD, Cedars-Sinai Medical Center, Los Angeles, said she voted yes “on the basis of need,” and her personal experience, as well as the data presented, that “up to half of severe heart failure patients are intolerant of guidelines directed medical therapy.”

Christopher M. O’Connor, MD, with Inova Heart and Vascular Institute, Falls Church, Va., who also voted in favor of approval for the drug, cited the “important unmet need,” and said he believes “a path was constructed in which one could go forward safely and with enhanced efficacy.

“It may be a narrow path, but I think it’s a path that would afford a lot of benefit to this high-risk patient population,” said Dr. O’Connor.

Those who voted against approval generally felt the benefit was not large enough and that more data are needed, given this is a first-in-class agent.

Julia B. Lewis, MD, Vanderbilt Medical Center, Nashville, Tenn., who voted no, said she was concerned that, despite the large size of the trial, “a more positive effect could not have been found.” She was also concerned that there was no benefit on quality of life or any other secondary outcomes. 

David J. Moliterno, MD, University of Kentucky Medical Center, Lexington, who also voted no, felt the benefits were “more singular and that being a modest reduction primarily limited to fewer outpatient visits.” Dr. Moliterno, like many of the committee members who voted no, called for more study.

The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.

As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.

This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.

The results were presented at the American Heart Association 2020 scientific sessions and simultaneously published in the New England Journal of Medicine.

In a statement, Robert I. Blum, president and CEO of Cytokinetics, said, “We are disappointed there was not a greater consensus amongst committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF.”

He added that the company plans to engage constructively with the FDA as it completes its review of the application for omecamtiv mecarbil. 

The drug has a Prescription Drug User Fee Act target date of Feb. 28, 2023.

A version of this article first appeared on Medscape.com.

A panel of advisers to the Food and Drug Administration has recommended against approval of omecamtiv mecarbil (Cytokinetics) for the treatment of heart failure with reduced ejection fraction (HFrEF).

Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA Cardiovascular and Renal Drugs Advisory Committee on Dec. 13 voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF.

Those who voted in favor of the drug cited the clinical benefit (albeit small) and good safety profile of the drug as well as the unmet need for new treatments.

C. Noel Bairey Merz, MD, Cedars-Sinai Medical Center, Los Angeles, said she voted yes “on the basis of need,” and her personal experience, as well as the data presented, that “up to half of severe heart failure patients are intolerant of guidelines directed medical therapy.”

Christopher M. O’Connor, MD, with Inova Heart and Vascular Institute, Falls Church, Va., who also voted in favor of approval for the drug, cited the “important unmet need,” and said he believes “a path was constructed in which one could go forward safely and with enhanced efficacy.

“It may be a narrow path, but I think it’s a path that would afford a lot of benefit to this high-risk patient population,” said Dr. O’Connor.

Those who voted against approval generally felt the benefit was not large enough and that more data are needed, given this is a first-in-class agent.

Julia B. Lewis, MD, Vanderbilt Medical Center, Nashville, Tenn., who voted no, said she was concerned that, despite the large size of the trial, “a more positive effect could not have been found.” She was also concerned that there was no benefit on quality of life or any other secondary outcomes. 

David J. Moliterno, MD, University of Kentucky Medical Center, Lexington, who also voted no, felt the benefits were “more singular and that being a modest reduction primarily limited to fewer outpatient visits.” Dr. Moliterno, like many of the committee members who voted no, called for more study.

The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.

As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.

This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.

The results were presented at the American Heart Association 2020 scientific sessions and simultaneously published in the New England Journal of Medicine.

In a statement, Robert I. Blum, president and CEO of Cytokinetics, said, “We are disappointed there was not a greater consensus amongst committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF.”

He added that the company plans to engage constructively with the FDA as it completes its review of the application for omecamtiv mecarbil. 

The drug has a Prescription Drug User Fee Act target date of Feb. 28, 2023.

A version of this article first appeared on Medscape.com.

A panel of advisers to the Food and Drug Administration has recommended against approval of omecamtiv mecarbil (Cytokinetics) for the treatment of heart failure with reduced ejection fraction (HFrEF).

Omecamtiv mecarbil is a first-in-class, selective cardiac myosin activator designed to improve cardiac performance.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA Cardiovascular and Renal Drugs Advisory Committee on Dec. 13 voted 8 to 3 (with no abstentions) that the benefits of omecamtiv mecarbil do not outweigh the risks for HFrEF.

Those who voted in favor of the drug cited the clinical benefit (albeit small) and good safety profile of the drug as well as the unmet need for new treatments.

C. Noel Bairey Merz, MD, Cedars-Sinai Medical Center, Los Angeles, said she voted yes “on the basis of need,” and her personal experience, as well as the data presented, that “up to half of severe heart failure patients are intolerant of guidelines directed medical therapy.”

Christopher M. O’Connor, MD, with Inova Heart and Vascular Institute, Falls Church, Va., who also voted in favor of approval for the drug, cited the “important unmet need,” and said he believes “a path was constructed in which one could go forward safely and with enhanced efficacy.

“It may be a narrow path, but I think it’s a path that would afford a lot of benefit to this high-risk patient population,” said Dr. O’Connor.

Those who voted against approval generally felt the benefit was not large enough and that more data are needed, given this is a first-in-class agent.

Julia B. Lewis, MD, Vanderbilt Medical Center, Nashville, Tenn., who voted no, said she was concerned that, despite the large size of the trial, “a more positive effect could not have been found.” She was also concerned that there was no benefit on quality of life or any other secondary outcomes. 

David J. Moliterno, MD, University of Kentucky Medical Center, Lexington, who also voted no, felt the benefits were “more singular and that being a modest reduction primarily limited to fewer outpatient visits.” Dr. Moliterno, like many of the committee members who voted no, called for more study.

The committee’s decision was based on results from the phase 3 GALACTIC-HF trial, which enrolled 8,256 patients with HFrEF who were at risk of hospitalization and death, despite standard-of-care therapy.

As previously reported by this news organization, omecamtiv mecarbil produced a positive result for the study’s primary endpoint, with a 2.1% absolute reduction in the combined rate of cardiovascular (CV) death, first HF hospitalization, or first urgent visit for HF, compared with placebo during a median follow-up of about 22 months.

This represented an 8% relative risk reduction and broke down as a 0.6% absolute drop in CV death, compared with placebo, a 0.7% cut in HF hospitalization, and a 0.8% drop in urgent outpatient HF visits.

The results were presented at the American Heart Association 2020 scientific sessions and simultaneously published in the New England Journal of Medicine.

In a statement, Robert I. Blum, president and CEO of Cytokinetics, said, “We are disappointed there was not a greater consensus amongst committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF.”

He added that the company plans to engage constructively with the FDA as it completes its review of the application for omecamtiv mecarbil. 

The drug has a Prescription Drug User Fee Act target date of Feb. 28, 2023.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 years and older and for use during pregnancy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The G7 has several improvements over the current G6 model, including a 60% smaller size, a 30-minute warm-up period (compared with 2 hours), an all-in-one sensor and transmitter (as opposed to the two separate devices), a mean absolute relative difference (compared with a standard, an assessment of accuracy) of 8.2% (compared with 12.8%), a 12-hour grace period (in contrast to the G6’s hard shutoff), and a redesigned mobile app.

It is indicated for wear on the back of the upper arm for people aged 2 years and older or the upper buttocks for ages 2-17 years old.

As an “integrated” CGM, the G7 has the capacity to work as part of automated insulin delivery systems, but that will require further FDA action. “Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible,” the company said in a statement.

Like the G6, it requires no fingersticks, scanning, or calibration. It provides real-time glucose readings every 5 minutes to a compatible device, including Apple Watch and other digital health apps, and allows for remote monitoring of data by as many as 10 followers.

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage with availability for G7, the statement says.

The Dexcom G7 was granted a CE Mark (Conformité Européenne) in March 2022, which means it is approved for use in people with diabetes aged 2 years and older, including pregnant women, in Europe.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration issued a letter to health care providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Earlier, the agency announced shortages of the company’s Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datascope IABP systems to the list.

The company’s letter explains that “ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps, intra-aortic balloon catheters, and spare parts due to raw material shortages.”

It also offers guidance on maintaining Cardiosave Safety Disks and lithium-ion batteries in the face of the shortages. “In the event that you need a replacement pump while your IABP is undergoing service, please contact your local sales representative who may be able to assist with a temporary IABP.”

Providers are instructed to inform the company through its sales representatives “if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need.”

The shortages are expected to continue into 2023, the FDA states in its letter.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration issued a letter to health care providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Earlier, the agency announced shortages of the company’s Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datascope IABP systems to the list.

The company’s letter explains that “ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps, intra-aortic balloon catheters, and spare parts due to raw material shortages.”

It also offers guidance on maintaining Cardiosave Safety Disks and lithium-ion batteries in the face of the shortages. “In the event that you need a replacement pump while your IABP is undergoing service, please contact your local sales representative who may be able to assist with a temporary IABP.”

Providers are instructed to inform the company through its sales representatives “if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need.”

The shortages are expected to continue into 2023, the FDA states in its letter.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration issued a letter to health care providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Earlier, the agency announced shortages of the company’s Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datascope IABP systems to the list.

The company’s letter explains that “ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps, intra-aortic balloon catheters, and spare parts due to raw material shortages.”

It also offers guidance on maintaining Cardiosave Safety Disks and lithium-ion batteries in the face of the shortages. “In the event that you need a replacement pump while your IABP is undergoing service, please contact your local sales representative who may be able to assist with a temporary IABP.”

Providers are instructed to inform the company through its sales representatives “if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need.”

The shortages are expected to continue into 2023, the FDA states in its letter.

A version of this article first appeared on Medscape.com.

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

The U.S. Food and Drug Administration has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.

The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.

Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.

About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.

“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.

This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.

Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).

The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.

The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).

Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”

The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.

Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.

The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.

The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.

Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.

In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.

In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.

Further details are available in the full prescribing information.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.

The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.

Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.

About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.

“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.

This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.

Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).

The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.

The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).

Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”

The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.

Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.

The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.

The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.

Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.

In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.

In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.

Further details are available in the full prescribing information.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved olutasidenib (Rezlidhia) for use in certain patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.

The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.

Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.

About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.

“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.

This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.

Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).

The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.

The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).

Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”

The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.

Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.

The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.

The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.

Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.

In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.

In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.

Further details are available in the full prescribing information.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration is moving to further restrict the use of certain PARP inhibitors in patients with ovarian cancer, citing recent data showing an increased risk for death with the agents versus chemotherapy.

These restrictions could mean bankruptcy for one company.

Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.

Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.

The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.

On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.

The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.

The company noted, however, that its first-line indication remains unchanged.

The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.

According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.

In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”

Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.

Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.

However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”

The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”

The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”

A version of this article first appeared on Medscape.com.