CHMP recommends Bavencio + axitinib for first line treatment of renal cell carcinoma. Merck KGaA + Pfizer

Merck KGaA and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Bavencio (avelumab) in combination with axitinib (Inlyta) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The opinion was based on positive findings from the Phase III JAVELIN Renal 101 study, which demonstrated a significant extension in median progression-free survival (PFS) and a clinically meaningful improvement in objective response rate (ORR) for the combination across all prognostic risk groups compared with sunitinib. The CHMP positive opinion will be reviewed by the European Commission (EC), with a decision anticipated in the fourth quarter of 2019. Merck KGaA and Pfizer have a global strategic alliance to jointly develop and commercialize Bavencio.