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°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted its first marketing authorization application for its novel in-house developed anticancer 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, PDGFRα, KIT and RET, involved in angiogenesis and tumor 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 multicenter, randomized, 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).

Compared to placebo, lenvatinib achieved a statistically significant improvement (Hazard Ratio (HR) 0.21, p<0.0001) in progression free survival (PFS), which was the primary objective of the study. The five most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension, diarrhea, decreased appetite, weight loss and nausea. The most common TRAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) included hypertension, proteinuria, weight loss, diarrhea, and decreased appetite.

The number of patients with thyroid cancer in Japan is estimated to be between 13,000 and 29,000. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Lenvatinib was granted Orphan Drug Designation for thyroid cancer in Japan, Europe and the U.S. Eisai is currently preparing to submit regulatory applications for lenvatinib to health authorities in the United States (U.S.) and Europe in the second quarter of fiscal 2014. Eisai has also initiated a global Phase Ⅲ trial of lenvatinib in hepatocellular carcinoma and is conducting Phase Ⅱ studies of lenvatinib in several other tumor types. Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.