BRIEF—Eisai applies for additional indication for Lenvima in Japan

Japanese drugmaker Eisai and Merck & Co’s subsidiary MSD KK announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate).

In June 2020, Lenvima received orphan drug designation in Japan for unresectable thymic carcinoma.

This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical Phase II study (NCCH1508) conducted in Japan, evaluating Lenvima as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen