The US Food and Drug Administration (FDA) has approved the combination of Bristol Myers Squibb’ Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) as a first line therapy for advanced renal cell carcinoma (RCC), a type of kidney cancer.

As per the FDA approval, Opdivo 240mg has to be injected intravenously every two weeks or 480mg every four weeks along with 40mg daily once tablets of Cabometyx. The FDA approval for the Opdivo, Cabometyx combination follows the priority review designation granted by the regulator for the disease last October.

The application for the Opdivo, Cabometyx combination was reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot program, which strives to make safe and effective treatments to patients accessible as soon as possible.

A PD-1 immune checkpoint inhibitor, Opdivo has been approved as either a monotherapy or in combination with other drugs for the treatment of various types of cancer. On the other hand, Cabometyx is an FDA-approved drug for the treatment of advanced renal cell carcinoma and liver cancer.

Adam Lenkowsky – general manager and head, US, Oncology, Immunology, Cardiovascular, Bristol Myers Squibb said: “At Bristol Myers Squibb, we are focused on developing transformative medicines that may improve survival for people living with cancer. 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 FDA approval for the Opdivo, Cabometyx combination has been granted on the basis of a phase 3 clinical trial called CheckMate -9ER. In the CheckMate -9ER trial, the two drug-regimen was evaluated in comparison to Pfizer’s FDA-approved renal cell carcinoma drug sunitinib in 651 randomized patients with advanced renal cell carcinoma.

The Opdivo, Cabometyx combination increased the survival rate of patients twice and their tumors did not progress as compared to subjects in the sunitinib group.

Besides, the combination regimen delivered a 40% reduction in the risk of death in comparison to the sunitinib arm.

Michael M. Morrissey – President and CEO of Exelixis said: “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.

“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.”

  Adam Lenkowsky, CABOMETYX, cabozantinib, Exelixis, FDA, Food and Drug Administration, Michael M. Morrissey, Nivolumab, Oncology, Opdivo, renal cell carcinoma, US FDA, US Food and Drug Administration, USA, Yervoy