Posted by Michael Wonder on 11 Feb 2019
FDA accepts sBLA and grants priority review for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
11 February 2019 - Merck and Pfizer today announced that the US FDA has accepted for priority review the supplemental biologics license application for Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma.
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 2018 Congress in Munich. In December 2017, the FDA granted Breakthrough Therapy Designation for Bavencio in combination with Inlyta for treatment-naïve patients with advanced renal cell carcinoma.
