Drugs

Carvykti Improves Survival in Phase 3 Trial: J&J

Johnson & Johnson says its Carvykti (ciltacabtagene autoleucel) achieved a statistically significant and clinically meaningful improvement in overall survival in multiple myeloma patients in the Phase 3 CARTITUDE-4 study. A company statement says the trial evaluated Carvykti compared to standard therapies to treat patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.

The statement says FDA approved Carvykti in 2/2022 to treat adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy. In April, it was approved to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy and who are refractory to lenalidomide, following an FDA Oncologic Drugs Advisory Committee 11-0 vote in favor of the new indication.

Carvykti is described as a BCMA-directed, genetically modified, autologous T-cell one-time infusion immunotherapy that involves reprogramming a patient’s T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T-cells to eliminate cells that express BCMA.

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