FDA approves Opdivo in combination with Cabometyx as first-line treatment for patients with advanced renal cell carcinoma.- BMS

Bristol Myers Squibb announced that Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on the Phase III CheckMate -9ER trial, which compared Opdivo in combination with Cabometyx (n=323) versus sunitinib (n=328) in patients with advanced RCC. This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. “This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. 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, M.D., 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.”