Drugs

Nuvalent NDA for ROS1 Inhibitor in Lung Cancer

FDA has accepted for review a Nuvalent NDA for zidesamtinib, a next-generation ROS1-selective tyrosine kinase inhibitor (TKI) being developed for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) previously treated with at least one ROS1 TKI. The agency set a user fee review action target date of 9/18/2026.

The submission is based on data from the global Phase 1-2 ARROS-1 trial, which enrolled patients with ROS1-positive NSCLC who had progressed on an earlier ROS1 inhibitor. Nuvalent says the data showed an objective response rate of approximately 48-51% in the overall TKI pre-treated population.

Zidesamtinib is said to be engineered to address resistance mutations, including the commonly treatment-emergent G2032R mutation that limits the efficacy of currently available ROS1 inhibitors. The company also states that it designed the drug to achieve strong central nervous system penetration, thereby improving outcomes for patients with brain metastases, while avoiding inhibition of the related tropomyosin receptor kinase (TRK) family to minimize central nervous system-related side effects commonly associated with dual ROS1/TRK inhibitors.

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