Drugs

Array Wins Full Approval for Colorectal Cancer Therapy

FDA has granted Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combination regimens to treat certain patients with metastatic colorectal cancer (CRC).

Encorafenib previously received accelerated approval in 2024 in combination with cetuximab and mFOLFOX6 for previously untreated metastatic CRC with a BRAF V600E mutation. The new action converts that conditional authorization into traditional approval following verification of clinical benefit through a confirmatory trial. The trial met its primary endpoints. Median progression-free survival was 12.8 months in the encorafenib-containing arm versus 7.1 months in the control arm, an FDA release says. Overall survival, a key secondary endpoint, was 30.3 months in the experimental arm compared with 15.1 months in the control arm.

FDA notes that the prescribing information for encorafenib includes warnings and precautions for new primary malignancies, including cutaneous and noncutaneous cancers; tumor promotion in BRAF wild-type tumors; cardiomyopathy; hepatotoxicity; hemorrhage; uveitis; QT prolongation; and embryo-fetal toxicity.

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