Eisai Co. Ltd. and Merck & Co. Inc. said the National Medical Products Administration of China approved Lenvima for treating patients with a type of liver cancer.
The Chinese regulator approved the drug as a single therapy for patients with hepatocellular carcinoma whose cancers could not be removed through surgery and those who have not received prior systemic therapy.
The nod is based on results of a phase 3 study called Reflect that showed lenvatinib was as effective as Bayer AG's Nexavar, or sorafenib, with meaningful improvements in progression-free survival and objective response rate.
The regulator, previously known as the China Food and Drug Administration, accepted the new drug application for Lenvima in October 2017 and granted the therapy priority designation in December 2017.
About 395,000 new cases of liver cancer are diagnosed in China each year. Hepatocellular carcinoma is the most common type of liver cancer.
Lenvima is a kinase inhibitor designed to block certain enzymes that promote cancer growth and is jointly developed by Kenilworth, N.J.-based Merck & Co., and Japan's Eisai. The therapy is also approved for treating liver cancer in Japan, U.S. and Europe.
Lenvima is also approved to treat thyroid cancer in more than 50 countries, including in Europe, Japan and the U.S.