FDA approves cabozantinib in combination with nivolumab for RCC

The U.S. Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx; Exelixis, Inc) in combination with nivolumab (Opdivo; Bristol Myers Squibb) as a first-line treatment in patients with advanced renal cell carcinoma (RCC).

Approval is based on the phase 3 CheckMate -9ER trial which compared cabozantinib in combination with nivolumab to sunitinib in patients with previously untreated advanced or metastatic RCC. The combination treatment significantly improved overall survival (OS) compared with sunitinib (HR= 0.60, 98.89% CI 0.40-0.89; P = 0.001). Median progression-free survival (PFS) and objective response rate (ORR) was 16.6 months and 56% in the combination group compared with 8.3 months and 27% in the sunitinib group.

“As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that Cabometyx in combination with OPDIVO is now available for the first-line treatment of patients with advanced kidney cancer,” said Michael M. Morrissey, PhD, President and Chief Executive Officer of Exelixis, in a press release. “This approval is a meaningful milestone for this patient community and speaks to the broad potential of Cabometyx as we continue to generate important clinical trial results supporting its use in combination with immune checkpoint inhibitors to benefit patients with other difficult-to-treat cancers. We would like to thank the clinical trial participants, the physicians and their staff who participated in the CheckMate -9ER trial and to acknowledge the team at the FDA for their collaboration during the review of our application.”

Read the full press release here.