Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

January 25, 2021 Auto Bot 1L, Advanced Renal Cell Carcinoma, Exelixis, FDA, patients, receives, regulatory, Treatment 0

Shots:

  • 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

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