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# Merck’s Keytruda OK’d in Endometrial Carcinoma
- URL: https://www.fdaweb.com/mercks-keytruda-okd-in-endometrial-carcinoma/
- Published: 2022-03-21T12:00:00.000Z
- Updated: 2026-09-14T17:37:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151414

FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test. The therapy is indicated for those who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-advanced-endometrial-carcinoma?ref=fdaweb.com). Simultaneous approval was given to Ventana Medical Systems for its companion diagnostic device, the Ventana MMR RxDx Panel.

Keytruda’s approval was based on data from the KEYNOTE-158 trial in 90 patients with unresectable or metastatic MSI-H or dMMR endometrial carcinoma. Data showed that the objective response rate was 46%, FDA says, but median duration of response was not reached, with 68% having response durations greater than 12 months and 44% having response durations greater than 24 months.

On the safety side, the common adverse reactions occurring in patients were fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritis, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism, FDA says.