ROCKLAND, Mass. and NEW YORK, May 14, 2019 /PRNewswire/ — BAVENCIO is the first anti-PD-L1 in combination with INLYTA approved by FDA for first-line treatmen
Source: www.prnewswire.com
EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer Inc. (NYSE: PFE) announced Tuesday that the US Food and Drug Administration (FDA) has approved BAVENCIO (avelumab) in combination with INLYTA (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval was based on positive results from a Phase III JAVELIN Renal 101 study, in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months in the intent-to-treat (ITT) patient population. The European Medicines Agency validated the Type II variation application for BAVENCIO in combination with INLYTA in advanced RCC in March 2019, and a supplemental application for BAVENCIO in combination with INLYTA in unresectable or metastatic RCC was submitted in Japan in January 2019.
