Drugs

Krazati’s Accelerated Approval for Colorectal Cancer Withdrawn

FDA has acknowledged that Bristol Myers Squibb’s (BMS) accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults with previously treated, KRAS G12C-mutated locally advanced or metastatic colorectal cancer has been voluntarily withdrawn by the company. The action was based on a ( xxx delete failed XX)confirmatory trial that failed to verify the clinical benefit behind its accelerated approval.

Recent results from the Phase 3 KRYSTAL-10 trial demonstrated antitumor activity, but it failed to achieve either of the trial’s dual primary endpoints. Median progression-free survival was 7.5 months with adagrasib plus cetuximab versus 8.1 months with chemotherapy, according to data presented at the ESMO Gastrointestinal Cancers Congress in July. Median overall survival was 21.6 months versus 21.7 months, respectively.

The withdrawal applies specifically to the colorectal-cancer indication. Krazati remains approved for certain patients with KRAS G12C-mutated non-small cell lung cancer.

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