EMA’s CHMP Recommends Eisai’s LenvimaBy
Eisai Co., Ltd. reports that its UK subsidiary, Eisai Europe Ltd.,has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on its anticancer agent Lenvima (lenvatinib mesylate) for treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, HÃ¼rthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
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. In particular, the agent simultaneously inhibits VEGFR, FGFR, RET, KIT and PDGFR, and RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray co-crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid binding to the target molecule and potent inhibition of kinase activity, according to kinetic analysis.
Lenvima was launched in the United States 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 on March 26, 2015. Currently, the agent is undergoing regulatory review in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.