Opdivo Plus Cabometyx Approved for Advanced Kidney Cancer

Kidney Cancer
The approval was based on data from the randomized, open-label phase 3 CheckMate-9ER.

The Food and Drug Administration (FDA) has approved Opdivo® (nivolumab injection; Bristol Myers Squibb) in combination with Cabometyx® (cabozantinib tablets; Exelixis) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The approval was based on data from the randomized, open-label phase 3 CheckMate-9ER trial that compared the efficacy and safety of nivolumab, a programmed death receptor-1 blocking antibody, plus cabozantinib, a tyrosine kinase inhibitor, to sunitinib in 651 adults with previously untreated advanced or metastatic RCC. Results showed a statistically significant improvement in progression-free survival, overall survival, and objective response rate for patients randomized to nivolumab plus cabozantinib compared with sunitinib. 

The most common adverse reactions (incidence of greater than or equal to 20%) observed with nivolumab plus cabozantinib were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

“The therapeutic benefit demonstrated in CheckMate-9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Toni Choueiri, MD, director, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”


U.S. Food and Drug Administration approves Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma. [press release]. Princeton, NJ: Bristol Myers Squibb; January 22, 2021.