Drugs

ODAC Looking at Increased Deaths in 2 Drugs

FDA is asking the Oncologic Drugs Advisory Committee to discuss on 3/15 an increased number of deaths in two cancer drugs whose manufacturers have submitted sBLAs for a new indication. The committee will consider the sBLA submitted by Celgene for its Abecma (idecabtagene vicleucel) to treat adults with relapsed or refractory multiple myeloma who have received an immunomodulatory agent and an anti-CD38 monoclonal antibody, and the sBLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide (Celgene’s Revlimid).

An agency briefing document on the Abecma sBLA asks the committee to discuss an increased number of early deaths in the Abecma arm of the KarMMa-3 trial compared to the standard of care arm, and whether the overall benefit/risk assessment is favorable given the higher rate of early deaths.

The Carvykti briefing document cites an increased number of early deaths in the Carvykti arm of the CARTITUDE-4 trial compared to the standard of care. The document says the adequacy of trial exploratory analyses to support the identification of strategies to mitigate the risk of early deaths warrants further discussion.

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