Drugs

Oncology Trial Overall Survival Assessment Guide

FDA has published a draft guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials, with recommendations for sponsors on assessing overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a pre-specified safety endpoint. The document’s recommendations are based in part on discussions at a 7/2023 public workshop held by FDA, the American Association for Cancer Research, and the American Statistical Association.

“While the guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint,” it says, “this guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint. Additionally, this guidance focuses on the assessment of overall survival in randomized trials. In general, time-to-event endpoints (e.g., overall survival, progression-free survival, etc.) are challenging to interpret in single-arm trials due to a lack of a randomized control arm to demonstrate that the experimental treatment results in an improvement in the time-to-event endpoint.”

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