Biologics

Merus Zeno BLA Gets 3 Month Review Extension

FDA has extended by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. The extension will give FDA additional time to review information recently submitted in response to a chemistry, manufacturing and controls information request, the company says, adding that no additional clinical data have been requested. The revised user fee review action target date is now 2/4/2025.

The NDA is based on data from the Phase 1/2 eNRGy trial (NCT02912949) that is assessing the antitumor activity and safety of zenocutuzumab in patients with various NRG1 fusion–positive solid tumors, including those with NSCLC or PDAC. The company earlier reported that treatment with zenocutuzumab showed an objective response rate of 34%, with target lesion reductions reported in 78% of patients. Additionally, the median duration of response was 12.9 months, with ongoing responses highlighted in 50% of patients at the time of the analysis.

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