Eisai Co., Ltd.  announced today that its U.K. subsidiary Eisai Europe Ltd. has received approval from the European Commission (EC) for anticancer agent Lenvima (lenvatinib mesylate) in the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radio-active 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.

The decision by the EC was based on the results of a multicenter, randomized, double-blind, placebo-controlled Phase III study (the SELECT study) on progressive RAI refractory DTC. In the study's primary endpoint of progression-free survival (PFS), Lenvima demonstrated a statistically significant extension in PFS compared to placebo (p<0.001; median PFS in the Lenvima group: 18.3 months, median PFS in the placebo group: 3.6 months; Hazard Ratio (HR) 0.21 [99% CI: 0.14-0.31]). In addition, the study underlines the rapid response of Lenvima, with a median time to first objective response of 2.0 months. Furthermore, Lenvima demonstrated a statistically significant improvement in objective response rate (number of objective responders [%]) compared to placebo (p<0.001; Lenvima: 64.8% vs placebo: 1.5%). In particular, complete response was observed in 1.5% (4 patients) of the Lenvima group and none in the placebo group. The most common Lenvima treatment-related adverse events were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.

For more details, go to: http://www.eisai.com/news/enews201539pdf.pdf