Drugs

Study Urges FDA to Tighten Surrogates in Oncology Approvals

A new study says that many surrogate endpoints used to support most new cancer drugs approved by FDA lack formal empirical verification of the surrogate-survival association’s strength, and this practice should be reconsidered. Published in the June issue of Mayo Clinic Proceedings, the study questions whether the agency is adhering to standards that demand that surrogates be “reasonably likely to predict” clinical benefit or “established.”

Lead author Vinay Prasad, a hematologist at Oregon Health and Sciences University, and co-author Chul Kim, a researcher at the National Institutes of Health, studied 55 drugs approved based on a surrogate endpoint between January 2009 and December 2014. Twenty-five drugs received accelerated (provisional) approval, and 30 drugs received traditional (full) approval. Yet, the authors could not find any formal analyses of the strength of the surrogate-survival correlation for 14 drugs (56%) that received accelerated approval and 11 drugs (37%) that [Jim Dickinson] received traditional approval. “For drugs receiving accelerated approval, a level 1 analysis (the most robust analysis) had been performed on only four drugs,” they say. “For drugs receiving traditional approval, a level 1 analysis had been performed on 15, with only three finding a strong correlation.”

The authors note that the sizable use of unvalidated (and altogether untested) surrogates to approve cancer drugs “may further undermine the ability to conduct definitive trials of precision medicine. Once drugs are available, patients are naturally reluctant to participate in trials assessing their fundamental efficacy. Instead, we increasingly have to rely on case reports, a notoriously unreliable way to assess claims of efficacy.”

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