Lenvima + Afinitor (lenvatinib + everolimus) filed with EMA for renal cell carcinoma- Eisai

Eisai has submited a new Marketing Authorisation Application to the European Medicines Agency (EMA) for the use of Lenvima + Afinitor (lenvatinib + everolimus), to treat people with unresectable advanced or metastatic renal cell carcinoma who have received one prior vascular endothelial growth factor (VEGF)-targeted therapy. A similar application has already been submitted to the FDA. Lenvatinib was granted an accelerated assessment in Europe by the EMA in October 2015.

The application is based on a phase II trial of lenvatinib, which when used in combination with everolimus showed progression-free survival was significantly extended in people with metastatic renal cell carcinoma (mRCC) versus everolimus alone. People treated with the combination regimen experienced a median progression-free survival of 14.6 months compared with 5.5 months for those who received everolimus alone. These data were presented at the American Society of Clinical Oncology in June 2015 and more recently published in Lancet Oncology.