Posted by Michael Wonder on 21 Sep 2019
CHMP adopts positive opinion for Bavencio (avelumab) plus axitinib for first-line treatment of patients with advanced renal cell carcinoma
20 September 2019 - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% and improved objective response rate compared with sunitinib.
EMD Serono and Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending approval of Bavencio (avelumab) in combination with axitinib 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 and a clinically meaningful improvement in objective response rate (ORR) for the combination across all prognostic risk groups compared with sunitinib.
