Drugs

Merck Halts Keytruda Lung Cancer Trial

Merck has stopped its Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynparza (AstraZeneca’s PARP inhibitor) for treating patients with metastatic squamous non-small cell lung cancer. The decision was based on a recommendation from an independent data monitoring committee that reviewed data from a planned interim analysis and concluded the combination did not demonstrate an improvement in overall survival compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo, according to the company. Additionally, the analysis looked at progression-free survival, which was not statistically significant despite a numerical improvement compared to the control arm. Merck says that the safety profile in the trial was consistent with that observed in previously reported studies for the individual therapies, and no new safety signals were identified.

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