FDA approves Lenvima (lenvatinib mesylate) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma .- Eisai

Eisai Co., Ltd. announced that its U.S. subsidiary Eisai Inc. has received approval from the FDA for an additional indication for Eisai’s in-house developed novel anticancer agent (lenvatinib mesylate) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. This is the only combination regimen to significantly prolong progression-free survival (PFS) when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy.

The approval was based on a Phase II clinical study (Study 205) that compared the safety and efficacy of Lenvima alone, and in combination with everolimus, in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of Lenvima plus everolimus demonstrated a significant extension in PFS,showing a median progression-free survival nearly three times that of everolimus alone (median PFS 14.6 months versus 5.5 months, respectively).The combination regimen resulted in a 63% reduction in the risk of disease progression or death compared with everolimus alone, while the objective response rate was 37% versus 6%, respectively, The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue.

Comment: Lenvima was first approved in the US in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.