Drugs

FDA Grants Accelerated Approval to Zongertinib for Lung Cancer

FDA has granted Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations, as detected by an FDA-authorized test. Zongertinib is a kinase inhibitor evaluated under the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which aims to accelerate review of therapies addressing national health priorities, according to an agency release.

The approval is based on data from Beamion LUNG-1 (NCT04886804), a single-arm, open-label, multi-center trial involving 72 patients with HER2-mutant NSCLC who had not received prior systemic therapy for advanced disease. The trial demonstrated a 76% objective response rate, with 64% of responders maintaining a response for at least six months and 44% for at least 12 months, as assessed by blinded independent review using RECIST v1.1 criteria, FDA says.

Safety warnings in the prescribing information highlight potential hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity, it says.

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