Drugs

Merck Discontinues Keytruda Prostate Cancer Trial

Merck says it is discontinuing the Phase 3 KEYNOTE-641 trial evaluating Keytruda (pembrolizumab) in combination with enzalutamide and androgen deprivation therapy (ADT) for treating patients with metastatic castration-resistant prostate cancer, based on the recommendation of an independent data monitoring committee. An interim analysis found that the combination therapy did not demonstrate an improvement in radiographic progression-free survival or overall survival (OS), which are the primary endpoints, compared to placebo plus enzalutamide and ADT.

The company also announced that another Phase 3 trial, KEYNOTE-789, evaluating Keytruda in combination with pemetrexed plus platinum-based chemotherapy did not meet its dual primary endpoint of OS for treating patients with metastatic nonsquamous non-small cell lung cancer, with epidermal growth factor receptor-genomic tumor mutations, who have previously progressed on a tyrosine kinase inhibitor. “At the final analysis of the study, there was an improvement in OS for patients who received Keytruda plus pemetrexed with platinum-based chemotherapy compared to pemetrexed with platinum-based chemotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan,” Merck says. “At an earlier interim analysis, the trial’s other dual primary endpoint, progression-free survival was tested and showed an improvement in the Keytruda arm compared to chemotherapy alone, but these results did not reach statistical significance.”

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