Drugs

FDA Urged to Pull Failed Cancer Drugs Faster

University of Pennsylvania Perelman School of Medicines and Flatiron Health researchers say that given an increasing withdrawal of accelerated approval (AA) cancer drugs due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is “critical to balance early access against population-level exposure to cancer therapies with no benefit over standard of care.” Writing in an online JAMA Oncology letter, the researchers say earlier access and more rapid FDA responses to negative confirmatory trial data may minimize exposure to AA therapies with a lack of benefit.

The study found that between 2009 and 2022, FDA approved 48 drugs for 66 oncology-related indications under the AA program. Since 2009, it says, 15 indications (23%) have been withdrawn due to lack of benefit over standard of care.

The study cohort included 4,342 patients who received 6,560 eligible lines of therapy. The median time from AA to indication withdrawal was 46 months. Between AA and subsequent withdrawal, the researchers say, 1,361 oncology treatment indications (26.1%) involved an AA therapy that was subsequently withdrawn.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome