The FDA’s primary review team found that Replimune hadn’t sufficiently addressed deficiencies that had been pointed out in the two prior rejection letters for the melanoma therapy Tudriqev.
A director at the Center for Biologics Evaluation and Research overruled a team of FDA reviewers last month to hand Replimune an accelerated approval for the advanced melanoma therapy Tudriqev.
The primary reviewers in charge of the biotech’s application had agreed to reject Tudriqev, according to an Aug. 6 memo. This would have been the drug’s third rebuff, after an initial denial in July 2025 and another in April. The review team found that Replimune failed to address key deficiencies pointed out in the complete response letters that delivered those rejections.
In July, under former CBER director Vinay Prasad, the FDA said that Replimune’s data package was “insufficient to conclude substantial evidence of effectiveness” of the therapy in the proposed indication—adults with advanced melanoma who have experienced disease progression on an anti-PD-1 antibody-based regimen. The single-arm IGNYTE study appeared to be of particular concern to the FDA.
But a supportive advisory committee meeting in July—in which Replimune won a 10–3 vote, even as one independent panelist conceded that the company’s data were “messy”—factored heavily into the senior FDA official’s decision to ultimately grant the biotech an accelerated approval, according to the Aug. 6 memo.
Indeed, the regulatory greenlight was given “having carefully considered the totality of evidence and the advisory committee’s input, and exercising the regulatory flexibility afforded under the accelerated approval pathway,” the memo read.
The document also clarifies that the approval came with the “full acknowledgment of the remaining uncertainties” around Tudriqev, as well as the “explicit expectation” that the drug’s clinical benefit is verified in an ongoing Phase 3 confirmatory trial. This study, dubbed IGNYTE-3, is currently enrolling with topline data expected in September 2030.
In an opinion piece for BioSpace on Thursday, former Johns Hopkins anesthesiologist Shahriar Minokadeh argued that the outcome of Replimune’s advisory committee meeting—and by extension, Tudriqev’s approval—underscores the importance of having specialists and experts scrutinize an application, rather than entirely relying on the FDA’s internal teams, which are likely to be staffed by generalists.
“The panel reviewing Replimune’s immunotherapy RP1 for advanced melanoma showed how specialization changes outcomes,” wrote Minokadeh, who is living with amyotrophic lateral sclerosis (ALS). In particular, specialists were able to correct erroneous analyses from the agency’s reviewers while also recognizing the shortcomings of Replimune’s submission.
“That is what happens when true disease experts are in the room,” he wrote.
