Drugs

FDA Priority Review for Merck’s Keytruda in Lung Cancer

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The agency has set a user fee review target date of 12/24. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for the same indication.

The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study, which showed that Keytruda monotherapy resulted in superior progression-free survival as well as overall survival compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1, the company says. “Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive Keytruda,” it says.

The humanized monoclonal antibody works by increasing the ability of the body’s immune system to help detect and fight tumor cells, Merck says. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

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