- The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC.
- Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + Cabometyx also significantly reduced the risk of death by 40% vs Sutent alone , ORR 56% in combination and 27% sunitinib
- Application approved prior to PDUFA action date of Feb 20, 2021 and reviewed under the Real-Time Oncology Review pilot program
Click here to read full press release/ article | Ref: Businesswire | Image: Fierce Pharma