European Commission Approves Opdivo-Cabometyx Combination for Renal Cancer

Bristol Myers Squibb has secured European Commission approval for its blockbuster monoclonal antibody Opdivo (nivolumab) in combination with Exelixis’ Cabometyx (cabozantinib) as a first-line treatment for adult patients with advanced renal cell carcinoma.

The approval was supported by phase 3 data that showed the combination had superior efficacy vs. the chemotherapy drug sunitinib in terms of progression-free survival, objective response rate and overall survival.

The combination received FDA approval in January for the same indication, and the companies have submitted applications to other global regulators.

BMS earned almost $7 billion from Opdivo sales in 2020.