Bristol-Myers Squibb’s immuno-oncology combination of Opdivo (nivolumab) and Yervoy (ipilimumab) is now approved to treat four types of cancer after it was approved by the FDA to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.
Approval for this latest indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate -040 trial.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Opdivo + Yervoy is the only dual immunotherapy approved by the FDA in this setting. The therapy features a potentially synergistic mechanism of action that targets two different checkpoints (PD-1 and CTLA-4) and works in complementary ways.
The combination was granted Breakthrough Therapy Designation for this indication and a Priority Review from the FDA.
“The overall response rate observed in the Opdivo + Yervoy cohort of the CheckMate -040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients,” said lead investigator, Dr Anthony B. El- Khoueiry.