The decision gives Replimune its first marketed product after two prior FDA rejections and clears Tudriqev for use with Bristol Myers Squibb’s Opdivo in advanced melanoma.
Replimune Group said Thursday that the Food and Drug Administration approved Tudriqev for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, giving the biotech company its first marketed product after years of regulatory setbacks. The decision follows Replimune’s third bid for approval after the FDA twice declined the treatment, citing the single-arm IGNYTE study’s lack of a control group and insufficient evidence of effectiveness. The approval also comes after the regulator’s outside advisers last month voted 10-3 that the trial data were evaluable and showed clinically meaningful benefit.