Drugs

ODAC to Discuss Minimal Residual Disease Endpoint

The Oncologic Drugs Advisory Committee meets on 4/12 to discuss using minimal residual disease (MRD) as an endpoint in multiple myeloma (MM) clinical trials. An agency briefing document developed in conjunction with two applicants, the University of Miami and 12TEAMM, and distributed in advance of the meeting, says that no specific products will be presented or discussed at the meeting.

The committee will be asked to evaluate the totality of the data and to discuss the adequacy of the data to support the use of MRD as an endpoint to support accelerated approval in MM clinical trials.

FDA concludes that “the applicants have worked with the broader MM community to develop a novel endpoint of MRD that has the potential to expedite drug development in MM. While there are still outstanding questions on how to best use MRD, the meta-analyses conducted represent robust assessments of MRD that support its prognostic value, provide information regarding the appropriate timing of MRD assessment, and suggest that MRD may be appropriate to use as an intermediate clinical endpoint to support accelerated approval.”

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