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# Merck Keytruda sBLA for Endometrial Cancer
- URL: https://www.fdaweb.com/merck-keytruda-sbla-for-endometrial-cancer/
- Published: 2024-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:23:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156393

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for treating patients with primary advanced or recurrent endometrial carcinoma. The agency has set a user fee review action target date of 6/21.

The submission is based on data from the Phase 3 NRG-GY018 trial which showed the combination reduced the risk of disease progression or death by 46% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% in patients whose cancer was mismatch repair deficient (dMMR), compared to chemotherapy alone, Merck says.

Currently, Merck notes Keytruda is approved for two indications in endometrial cancer. One indication is for combination use with Eisai’s Lenvima (lenvatinib) in patients with advanced endometrial carcinoma that is pMMR and who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, it says. The second is as a single agent for patients who are dMMR and have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.