On July 21, 2021, the FDA granted full approval for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), in combination with the kinase inhibitor lenvatinib (Lenvima; Eisai), for the treatment of advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair-deficient), in patients whose disease progressed after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation. The FDA granted this combination a priority review and a breakthrough therapy designation for this indication. In September 2019, the FDA granted accelerated approval to the combination of pembrolizumab plus lenvatinib for this indication.
The current regular FDA approval of pembrolizumab plus lenvatinib for this indication was based on the confirmatory results of Study 309/KEYNOTE-775, a multicenter, open-label, randomized, active-controlled clinical trial conducted to confirm the clinical benefit of the previous accelerated approval.
Pembrolizumab and lenvatinib are each approved by the FDA for many indications, alone and in combination with other drugs.