U.S. Food and Drug Administration assigned a target action date of February 20, 2021
Applications based on pivotal Phase 3 CheckMate -9ER trial, which showed OPDIVO in combination with CABOMETYX improved overall survival, doubled median progression-free survival and objective response rate, and demonstrated a manageable safety profile
Results from CheckMate -9ER recently presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020
San Francisco, CA (UroToday.com) — Bristol Myers Squibb and Exelixis, Inc. announced that the U.S. Food and Drug Administration (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.