FDA accepts for priority review applications for Opdivo in combination with Cabometyx in advanced renal cell carcinoma. -BMS + Exelixis.

Bristol Myers Squibb and Exelixis, Inc. announced that the FDA has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for Opdivo(nivolumab) in combination with Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma (RCC). The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021. These filings were based on results from the Phase III CheckMate -9ER trial, which evaluated Opdivo in combination with Cabometyx in patients with previously untreated advanced RCC versus sunitinib. In CheckMate -9ER,Opdivo in combination with Cabometyx demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), progression-free survival (PFS) and objective response rate (ORR), versus the comparator, sunitinib.