Merck and Pfizer Inc. today 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 US Food and Drug Administration 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.
Despite available therapies, the outlook for patients with advanced RCC remains poor. Approximately 20% to 30% of patients are first diagnosed at the metastatic stage. The five-year survival rate for patients with metastatic RCC is approximately 12%.
The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and more than 9,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include breast, gastric/gastro-esophageal junction, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma.