Data from Pharmawand - Curated by EPG Health - Date added 09 March 2019

Merck and Pfizer Inc. announced that the European Medicines Agency (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 (RCC). 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. The FDA has also accepted a supplemental Biologics License Application for Bavencio in combination with Inlyta for patients with advanced RCC for Priority Review, with a target action date in June 2019. A supplemental application for the combination in unresectable or metastatic RCC has also been submitted in Japan.


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