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# Keytruda/Lenvima Combo Gains Full Approval
- URL: https://www.fdaweb.com/keytruda-lenvima-combo-gains-full-approval/
- Published: 2021-07-22T12:00:00.000Z
- Updated: 2026-09-14T17:07:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149766

FDA has granted full approval to the combination of Merck’s Keytruda and Eisai’s Lenvima for treating patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Previously, the combination had been granted accelerated approval. The companies say approval was based on data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which the drug combination demonstrated statistically significant improvements in overall survival, reducing the risk of death by 32%, and progression-free survival, reducing the risk of disease progression or death by 40%, versus chemotherapy.