Posted by Michael Wonder on 08 Mar 2019
European Medicines Agency validates application for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
8 March 2019 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation application for Bavencio (avelumab) in combination with Inlyta (axitinib) for the treatment of patients with advanced renal cell carcinoma.
With this validation, the application is complete, and the EMA will now begin the review procedure.
The application is based on results from the pivotal Phase III JAVELIN Renal 101 trial, which were published in the New England Journal of Medicine on February 16, 2019.
