July 22, 2016
Eisai Co., Ltd. has announced that its European regional headquarter has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency on anticancer agent lenvatinib mesylate (generic name,“lenvatinib”) in combination with everolimus for treating adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF) targeted therapy. Lenvatinib will be launched under the brand name Kisplyx® for this indication, if approved.
The positive opinion by CHMP was based on a Phase II clinical study (Study 205) that evaluated the efficacy and safety of lenvatinib in combination with everolimus in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy. The results of the study showed that the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival, the study’s primary endpoint, in addition to a higher objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, fatigue, and decreased appetite. The most common TEAEs of Grade 3 or higher were hypertension, diarrhea, and fatigue.
Currently lenvatinib has been launched in countries including Japan, the United States, and in Europe under the product name Lenvima® for treating refractory thyroid cancer. Moreover, in May 2016, lenvatinib was approved in combination with everolimus for treating patients with advanced renal cell carcinoma following one prior VEGF-targeted therapy by the U.S. Food and Drug Administration (FDA) in the United States.