Bristol-Myers Squibb plans to submit a Biologics License Application in the third quarter for its drug Opdivo for previously treated advanced melanoma, following discussions with the U.S. Food and Drug Administration, according to a recent press release.
This will be the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. For Michael Giordano, Head of Oncology Development Bristol-Myers Squibb, this represents “an important step forward” in the company’s “commitment to deliver innovative treatment options for patients with cancer.”
An investigational fully-human programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo merges with the checkpoint receptor PD-1 expressed on activated cancer cells, where these cells hide from the immune system and shield the tumor from immune attack.
Currently, the Bristol-Myers team is investigating whether blocking this pathway would allow Opdivo to enable the immune system to resume its ability to recognize attack and destroy cancer cells.
If approved by health authorities, the proposed name Opdivo will serve as the trade name for nivolumab.
As described in the FDA website, the Biologics License Application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. The advanced melanoma BLA is based on data from Checkmate -037, a multinational multicenter randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy (ipilimumab).