Eisai Gains EU OK for Cancer Drug
Eisai Co., Ltd.’s UK subsidiary, Eisai Europe Ltd., has received approval from the European Commission (EC) for the anticancer agent, Lenvima (lenvatinib mesylate) ,in the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, HÃ¼rthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima was granted an accelerated assessment by the European Medicines Agency, and was ultimately approved in approximately 9 months since the application was filed on August 14, 2014.
Lenvima was launched in the United States indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in February 2015. In addition, Lenvima was approved in Japan for the treatment of unresectable thyroid cancer in March 2015. Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules, including VEGFR, FGFR, RET, KIT, and PDGFR.