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