Merck Inc., provides update on Keytruda indication in third-line gastric cancer in the US.
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 III study. As agreed with the FDA, Merck will initiate the withdrawal in six months. Patients being treated with Keytruda for metastatic gastric cancer in the third- or further-line setting should discuss their care with their health care provider. This decision does not affect other indications for Keytruda.
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