Eisai Submits NDA for Lenvatinib (Lenvima) in Differentiated Thyroid Cancer, Accepted by China's NMPA

TOKYO, December 24, 2019 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; hereinafter referred to as "Eisai") recently announced that the application for an additional indication of lenvatinib mesylate (brand name: Lenvima; hereinafter referred to as "lenvatinib"), an oral kinase inhibitor developed by Eisai, for differentiated thyroid cancer has been accepted by the China National Medical Products Administration. This is the second indication applied for in China, following the approval for hepatocellular carcinoma in September 2018.

This application is primarily based on the results of the global SELECT study (Study 303) conducted in patients with radioactive iodine-refractory differentiated thyroid cancer. In the SELECT study, the primary endpoint was progression-free survival (PFS). The results demonstrated that lenvatinib significantly prolonged PFS compared with placebo, with a statistically significant difference (median PFS: 18.3 months in the lenvatinib group vs. 3.6 months in the placebo group; hazard ratio: 0.21 [99% confidence interval: 0.14–0.31]; p<0.001). Although a domestic Phase III clinical trial (Study 308) evaluating the efficacy of lenvatinib in radioactive iodine-refractory differentiated thyroid cancer is ongoing, Eisai may still submit this application in advance by leveraging the results from the SELECT study.

In China, there are approximately 190,000 newly diagnosed cases of thyroid cancer annually, with about 8,600 deaths each year. Although most types of thyroid cancer can be appropriately treated, there are few therapeutic options once the disease progresses; therefore, it remains a condition with significant unmet medical needs.

Eisai positions oncology as a key therapeutic area, aiming to discover revolutionary new drugs with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib, seeking to further meet the diverse needs of cancer patients, their families, and healthcare providers, thereby contributing to improved well-being.