Drugs

CAR T-Cell Benefits Outweigh Risks: Marks

CBER director Peter Marks says the benefits of chimeric antigen receptor T-cell (CAR-T) therapy far outweigh the risks involved, including secondary T-cell malignancies. Speaking 1/8 to the Alliance for Regenerative Medicine State of the Industry briefing, Marks said that while FDA issued a safety advisory for patients receiving CAR-T about T-cell malignancies at the end of 11/2023, only 22 cases out of more than 27,000 individuals treated had been reported by the end of 2023.

“Make no mistake,” he said, “the overall risk/benefit profile [for CAR-T] is still incredibly beneficial. For all of the approved uses, we don’t have any concerns with continued use of these products.”

He discussed the positive survival curves for children and young adults with acute lymphoblastic leukemia and adults with non-Hodgkin lymphoma and the “low amounts of toxicity” they have. “It doesn’t salvage everyone, which means we can always do better, but it’s really quite remarkable.”

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