EMA Advisory Committee Recommends New Use for Eisai Cancer Drug
Eisai has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on its anticancer-agent, lenvatinib mesylate, in combination with everolimus for adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The recommendation will next be reviewed by the European Commission, which has the authority to approve medicines for the European Union. If approved, lenvatinib will be launched under the brand name Kisplyx for this indication.
Lenvatinib has been launched in countries, including the US, Japan and in Europe, under the brand name Lenvima for treating refractory thyroid cancer. It was originally approved by the US Food and Drug Administration in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. In May 2016, the drug was approved by the FDA in combination with everolimus for patients with advanced RCC following one prior VEGF-targeted therapy.
Currently, Eisai has obtained approval of the drug for refractory thyroid cancer in over 40 countries, including in the US, Japan, Europe, Korea, Canada, and Mexico, and is undergoing regulatory review in other countries, including Brazil and South Africa. In Japan, Eisai has obtained approval for lenvatinib for unresectable thyroid cancer, and in Europe, for adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, HÃ¼rthle cell) thyroid carcinoma, refractory to radioactive iodine, respectively.
Eisai is also conducting clinical studies of lenvatinib in several other tumor types, including hepatocellular carcinoma (Phase III), endometrial carcinoma (Phase II), biliary tract cancer (Phase II), and in combination with an immune checkpoint inhibitor (Phase Ib/II).