Eisai submits first marketing authorisation for anti-cancer

Eisai Co., Ltd. announced that it has submitted its first marketing authorisation application for its novel in-house developed anti-cancer agent lenvatinib mesylate (“lenvatinib”) for the treatment of thyroid cancer in Japan. This application for Japan marks the first submission for lenvatinib in the world following the completion of a global clinical trial.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of various RTKs including VEGFR, FGFR, PDGFRa, KIT and RET, involved in angiogenesis and tumour proliferation.

The application submitted in Japan was based on a Phase III clinical study known as the SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) trial which was a multicentre, randomised, double-blind, placebo-controlled study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) and radiographic evidence of disease progression within the prior 13 months (patients may have received =1 prior VEGFR-targeted therapies).