Drugs

Patritumab BLA Pulled by Merck/Daiichi

Merck/Daiichi Sankyo have withdrawn their BLA for patritumab deruxtecan to treat patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer. A Merck statement says the decision to pull the BLA was based on topline results from the confirmatory HERTHENA-Lung02 Phase 3 trial in which overall survival did not meet statistical significance. It also followed discussions with FDA, the company says. The statement says the decision was not related to an FDA complete response letter that was issued in 6/2024 and outlined findings about an inspection of a third-party manufacturing facility.

Patritumab deruxtecan is described as a specifically engineered HER3-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi and Merck.

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