Merck to Pull Gastric Cancer Indication for Keytruda
The move follows an April 29 vote by the FDA Oncology Drugs Advisory Committee.
Merck announced late Thursday that it would voluntarily withdraw the U.S. accelerated approval indication for Keytruda (pembrolizumab) for certain patients with gastric cancer or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, based on parameters of an FDA-approved test, who have seen their disease progress after at least two lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. The decision follows the April 29 hearing of the FDA Oncology Drugs Advisory Committee, where the panel recommended against continuing the indication. As agreed with the FDA, Merck will initiate the withdrawal in six months. The decision does not affect other indications for Keytruda.
ICER Identifies 5 Drugs with Unsupported Price Increases
December 12th 2024The Institute for Clinical and Economic Review has identified five drugs — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — with prices increases that are not supported by new clinical evidence, with a total of $815 million in added costs to U.S. payers in 2023.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Sets Goal Date for Lymphoma Drug Columvi
December 5th 2024The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.
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