FDA approves Replimune's melanoma drug after two prior rejections

Aug 6, 2026

The FDA granted accelerated approval to Replimune's Tudriqev (RP1) in combination with nivolumab for advanced melanoma patients who progressed on anti-PD-1 therapy. The decision follows two prior rejections and a supportive advisory panel vote that overrode FDA staff concerns regarding trial design. Approval was based on the IGNYTE trial, which showed a 24.2% response rate lasting a median of 14.1 months. Continued approval is contingent on the Phase 3 IGNYTE-3 trial, expected to read out in late 2027.

FDA accelerated approval granted

▪Tudriqev is approved for use in combination with Bristol Myers Squibb's Opdivo, also known as nivolumab, for adults with unresectable advanced cutaneous melanoma whose disease progressed on anti-PD-1 therapy.
▪The Food and Drug Administration granted accelerated approval to Replimune's advanced melanoma drug Tudriqev, also known as RP1, on August 6, 2026.
▪Replimune announced that the list price of Tudriqev will be $450,000 per course of therapy before customary rebates and discounts.

IGNYTE trial efficacy results

▪In the Phase 1/2 IGNYTE trial, the combination of Tudriqev and nivolumab achieved an objective response rate of 24.2% among 91 efficacy-evaluable patients.
▪The median duration of response for patients treated with the Tudriqev and nivolumab combination in the IGNYTE trial was 14.1 months.
▪The IGNYTE trial's efficacy-evaluable population of 91 patients all had at least one non-injected lesion.

Safety profile tolerability

▪Adverse reactions led to the permanent discontinuation of the Tudriqev and nivolumab combination therapy in 2.9% of the 140 treated patients.
▪Serious adverse reactions occurred in 35% of the 140 patients treated with the Tudriqev and nivolumab combination in the IGNYTE trial.
▪The combination of Tudriqev and nivolumab was generally well tolerated, with most treatment-related adverse reactions being mild-to-moderate grade 1 and 2 transient events.

Prior FDA rejections history

▪Replimune accused the Food and Drug Administration of switching regulatory guidance after the drug's second rejection in April 2026.
▪Replimune had warned that it might have to scrap development of Tudriqev if the Food and Drug Administration rejected the therapy a third time.
▪The Food and Drug Administration previously rejected Replimune's melanoma drug twice before granting accelerated approval on August 6, 2026.

Advisory panel support

▪Advisory panel members believed there was a large enough efficacy signal and that advanced melanoma patients are in urgent need of new treatments.
▪Food and Drug Administration advisers voted in support of Tudriqev, disputing the arguments of agency scientists who challenged the trial design and efficacy measurements.

Confirmatory Phase 3 requirement

▪The ongoing Phase 3 IGNYTE-3 trial is testing the Tudriqev-Opdivo combination against PD-1 drugs or chemotherapy, with results expected in late 2027.
▪Continued approval of Tudriqev is contingent on verification of clinical benefit in the ongoing Phase 3 IGNYTE-3 confirmatory trial.