The European Medicines Agency Sept. 20 recommended approval of Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma.
The Committee for Medicinal Products for Human Use gave the positive opinion 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 for the combination across all prognostic risk groups compared with sunitinib.
The European Commission will review the opinion, with a decision anticipated in the fourth quarter of this year. Bavencio is sponsored by EMD Serono and Pfizer.
FDA approved Bavencio in combination with axitinib for the first-line treatment of patients with advanced RCC in May 2019. A supplemental application for Bavencio in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in Jan. 2019.
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