Bristol Myers Squibb (BMS) has secured approval from the US Food and Drug Administration (FDA) for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of advanced renal cell carcinoma (RCC).

The FDA approval is for Opdivo 240mg to be intravenously injected every two weeks or 480mg every four weeks in combination with 40mg once daily tablets of Cabometyx. The combination regimen was granted the priority review designation for the condition by the FDA in October 2020.

The regulator had reviewed the application for the Opdivo, Cabometyx combination under the Real-Time Oncology Review (RTOR) pilot programme, whose objective is to bring safe and effective treatments to patients as early as possible.

Opdivo is a PD-1 immune checkpoint inhibitor with approvals across various countries as either a monotherapy or in combination with other drugs for treating multiple types of cancer.

Cabometyx on the other hand was developed by Exelixis and has approvals in the US for the treatment of advanced RCC and liver cancer.

Bristol Myers Squibb US oncology, immunology, cardiovascular general manager and head Adam Lenkowsky said: “The role of Opdivo + YERVOY is well established for intermediate/poor-risk patients with advanced RCC, and today’s achievement extends the potential of an Opdivo-based combination to even more patients.

“Opdivo in combination with Cabometyx brings together the strong heritage of both medicines to now provide physicians a new combination in advanced RCC that may offer improved outcomes to patients for whom an immunotherapy plus tyrosine kinase inhibitor regimen is appropriate.”

The approval by the regulator has been driven by the results of the phase 3 CheckMate -9ER trial. The late-stage randomised trial evaluated the Opdivo, Cabometyx in combination compared to sunitinib in 651 advanced RCC patients.

In the CheckMate -9ER trial, patients who were administered the Opdivo, Cabometyx combination lived twice as long without their tumours progressing compared to those in the sunitinib arm.

The combination regimen also cut down the risk of death by 40% when compared to sunitinib as per the findings of the late-stage trial.

Dana-Farber Cancer Institute Lank Center for Genitourinary Oncology director Toni Choueiri said: “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.

“With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”