Keytruda Gets Second FDA Approval for Endometrial Cancer

The FDA has approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) as a single agent for treatment of patients with advanced endometrial carcinoma that is microsatellite-instability high or mismatch-repair deficient.

The approval was based on phase 2 study results in 90 patients who received 200 mg of Keytruda intravenously every three weeks. Out of 41 patients who responded to the treatment, 68 percent had responses lasting 12 months or longer and 44 percent had responses lasting 24 months or longer.

Keytruda is approved for multiple cancer indications and it will be its second approval for endometrial cancer. The blockbuster drug earned almost $17.2 billion in 2021.