Drugs

FDA Shifting Accelerated Approval Approach: Attorneys

Attorneys Joshua Oyster and Rebecca Williams (Ropes & Gray) say recent FDA actions “potentially signal a broader shift in FDA’s approach to accelerated approval drugs.” Writing in an online post, they note the agency plans to hold workshops this year to discuss the role of surrogate efficacy endpoints, their ability to predict overall survival (OS), and the information necessary to make a risk/benefit determination for novel oncology drugs.

Explaining the agency’s 3/24 draft guidance on clinical trial considerations to support accelerated approval of oncology therapeutics, Oyster and Williams write that FDA expresses its preference for randomized clinical trials and also emphasizes endpoint selection, echoing recent agency concerns about the ability of surrogate endpoints to predict oncology drug clinical benefit.

They cite a recent article written by several FDA officials, including some from the Oncology Center of Excellence, that highlighted concerns about the ability of objective response rate (ORR) and progression-free survival (PFS) to serve as surrogate endpoints for OS. “While the article acknowledges that ORR and PFS continue to have utility in drug development,” the attorneys write, “there may be discordance between these earlier endpoints and OS due to, among other things, significant toxicity issues or inadequate exploration of dose optimization in earlier trials. The article emphasizes that the results and maturity of OS data may impact a sponsor’s ability to seek accelerated approval. Moreover, any detrimental effect on OS may cause FDA to reassess the risk/benefit profile of the product. The authors conclude that ‘when [risk/benefit is] unfavorable, both parties should honor the regulatory prenuptial agreement of drug approval and seek expedited withdrawal of the indication.’”

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