Drugs

Pluses, Minuses to FDA Oncology Trial Guidance

Rocky Mountain Cancer Center oncologist John Burke says a recent FDA guidance on approaches to assessment of overall survival in oncology clinical trials is likely to change future oncology trial designs potentially with both positive and negative effects. In a Targeted Oncology article, Burke lists these three important points from the guidance:

overall survival should be prioritized as the primary endpoint when feasible;
all randomized oncology clinical trials should be designed to assess overall survival to adequately evaluate the potential for harm; and
the use of crossover should be limited since it can confound treatment effect estimates.

Burke analyzes how those principles would play out if a specific trial he discusses were changed to meet the guidance.

“In my opinion,” he concludes, “FDA is trying to do the right thing by improving clinical trial design in oncology to ensure that trials correctly determine the risk/benefit ratio of novel agents. That said, we should be cognizant of the risks of higher costs to sponsors, impaired ability to enroll participants in trials, delayed read-outs on clinical trial results, and higher barriers to innovation.”

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