BRIEF— Full approval for Eisai's Lenvima in Japan

Nearly five years after it was granted conditional clearance for use in Japan, Lenvima’s (lenvatinib) authorization has been upgraded to a full approval.

The kinase inhibitor was approved in March 2015 for the treatment of unresectable thyroid cancer, subject to a post-marketing safety and efficacy study.

Japanese drugmaker Eisai submitted safety data for 604 patients and efficacy data for 601 patients to Japan’s Ministry of Health, Labour, and Welfare, and the regulator was sufficiently satisfied to grant full approval.

Eisai is co-commercializing Lenvima as part of an agreement with US pharma giant Merck & Co.