Tokyo-based Eisai Co. Ltd. said its drug Lenvima was approved in Japan as a primary treatment for liver cancer that cannot be removed surgically.
This is the first time the drug has been approved as a first-line treatment of unresectable hepatocellular carcinoma in the world.
It also marks the first approval of the drug under Eisai's global collaboration with Merck & Co. Inc. to co-develop and co-commercialize the treatment, either on its own or in combination with Merck's blockbuster drug Keytruda.
Eisai will receive a development milestone payment from Merck as a result of the approval which was based on the results of a late-stage clinical trial that demonstrated Lenvima was just as effective as Bayer AG's Nexavar on the primary endpoint.
Eisai's treatment proved to be better than Bayer's drug in the secondary endpoints which measured how long a patient lived without the disease worsening and reduction in a subject's cancer.
Analysts expect Lenvima to be a real contender to Bayer's Nexavar which has enjoyed a decadelong monopoly in the liver cancer market.
Eisai is also seeking approval of the drug in the U.S., EU and China as a treatment of hepatocellular carcinoma.
Lenvima, generically known as lenvatinib mesylate, is a kinase inhibitor that blocks cancer growth.