NEW YORK CITY (dpa-AFX) - EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. (PFE) announced that the US Food and Drug Administration 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-naïve patients with advanced RCC.
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