- Merck (NYSE:MRK) plans to voluntarily withdraw its U.S. accelerated approval indication for Keytruda for the treatment of certain patients with gastric cancer in the third line setting.
- The decision was made after Merck's blockbuster cancer drug failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a late-stage study, Merck said.
- Merck said that, as agreed with the U.S. health regulator, the company will initiate the withdrawal in six months, adding that the decision does not affect any of the other indications of Keytruda.
- 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, Merck said.