Posted by Michael Wonder on 30 Mar 2021
EMA accepts the marketing authorisation applications for two additional indications of anti-cancer agent lenvatinib in combination with pembrolizumab as a treatment for advanced renal cell carcinoma and advanced endometrial carcinoma
30 March 2021 - Eisai announced today that the EMA has confirmed it has accepted for review applications for the use of its in-house discovered multiple receptor tyrosine kinase inhibitor, lenvatinib mesylate (Lenvima/Kisplyx), in combination with anti-PD-1 therapy pembrolizumab (Keytruda), developed by Merck as a treatment for patients with advanced renal cell carcinoma and advanced endometrial carcinoma, respectively.
The application requesting an indication of lenvatinib in combination with pembrolizumab for renal cell carcinoma is based on the results of the pivotal Phase 3 CLEAR trial (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced renal cell carcinoma, which were presented at 2021 Genitourinary Cancers Symposium, and simultaneously published in the New England Journal of Medicine in February 2021.
