Bristol Myers Squibb’s Opdualag Gets FDA Nod for Patients With Melanoma

The FDA has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw) for the treatment of patients 12 years and older with unresectable or metastatic melanoma.

The approval was based on positive results from a phase 2/3 clinical trial in which 714 patients were randomized to receive either Opdualag or Opdivo (nivolumab). Opdualag more than doubled progression-free survival compared with Opdivo alone, the company said.

The application was approved through the FDA’s Real-Time Oncology Review program, a fast-track review that allows for earlier submission of topline efficacy and safety results prior to submission of the complete application.