Positive CHMP opinion for Opdivo + Cabometyx as first-line treatment advanced renal cell carcinoma.- BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The CHMP adopted the positive opinion based on results from the Phase III CheckMate -9ER trial (sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Inc., Ipsen and Takeda Pharmaceutical Company Limited.), which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib, with consistent efficacy benefits observed across key subgroups of patients. Opdivo combined with Cabometyx was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor (TKI) components in first-line advanced RCC. The full data from the CheckMate -9ER trial were presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.