New Application of Lenvatinib in Combination with Everolimus for Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC) Submitted to the European Medicines Agency (EMA) by Eisai

HATFIELD, England, January 12, 2016 /PRNewswire/ --


Lenvatinib, discovered and developed by Eisai, submitted for review for use in

combination with everolimus to treat people with metastatic kidney cancer 

Eisai today submits a new Marketing Authorisation Application to the European Medicines Agency (EMA) for the use of lenvatinib in combination with everolimus, to treat people with unresectable advanced or metastatic renal cell carcinoma who have received one prior vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib is an oral molecular tri-specific targeted therapy that has a potent selectivity. A similar application has already been submitted to the Food and Drug Administration in the U.S. 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 (HR 0.40; 95% CI: 0.24-0.68; p

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