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.