1 July 2021 - Merck today announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1 [combined positive score ≥1)] as determined by a U.S. FDA approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2/neu-targeted therapy.

The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for Keytruda as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase 3 trial. 

As agreed with the FDA, Merck will initiate the withdrawal in six months.

Read Merck press release