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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.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
