Drugs

Takeda sNDA for Alunbrig Expanded Use

FDA has granted Takeda Pharmaceutical Co. a priority review for a supplemental NDA that seeks to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Alunbrig is a next-generation tyrosine kinase inhibitor that was designed to target and inhibit ALK genetic alterations. It was originally approved 4/2017 for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib.

The new submission is based on data from the Phase 3 ALTA-1L trial. According to the company, the trial met its primary endpoint with Alunbrig “demonstrating superiority in blinded independent review committee-assessed progression-free survival compared to crizotinib.” Secondary endpoints included objective response rate, intracranial ORR, intracranial PFS, overall survival, safety and tolerability, it says. Alunbrig’s safety profile was generally consistent with the existing U.S. prescribing information.

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