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.
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