FDA accepts sBLA for Bavencio + Inlyta combination to treat renal cell carcinoma.- Pfizer + Merck KGaA.

Merck and Pfizer Inc. announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma (RCC). The application has been given a target action date in June 2019.

The submission is based on data from the pivotal Phase III JAVELIN Renal 101 trial, which were presented in a Presidential Symposium at the European Society of Medical Oncology (ESMO) 2018 Congress in Munich. In December 2017, the FDA granted Breakthrough Therapy Designation for Bavencio in combination with Inlyta for treatment-na�ve patients with advanced RCC. 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.