September 2021—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for 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.
The FDA granted accelerated approval on Sept. 17, 2019, to pembrolizumab with lenvatinib for advanced endometrial carcinoma. Study 309/KEYNOTE-775 was a multicenter, open-label, randomized, active-controlled trial required to confirm the clinical benefit of this accelerated approval.