The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today recommended the approval of the combination of avelumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
This recommendation is based on findings from the phase III JAVELIN Renal 101 study involving 886 patients, which demonstrated significant improvements 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. Overall survival data are not yet available for this study. Safety and tolerability were comparable between the two treatment groups.
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union, and a final decision is expected in the fourth quarter of 2019.