Replimune’s Tudriqev Gains FDA Accelerated Approval for Advanced Melanoma

On August 6, 2026, the U.S. Food and Drug Administration issued an accelerated approval for Replimune’s oncolytic virus therapy Tudriqev (vusolimogene oderparepvec-wtpg) combined with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed after anti-PD-1 therapy. The decision followed a July 30, 2026 advisory-committee vote of 10-3 that the IGNYTE trial data were evaluable and demonstrated clinically meaningful benefit.

MedscapeReplimune's Conditional Comeback: FDA Approval Ends a Bruising Regulatory Chapter Reuters

Tudriqev, previously RP1, had been rejected twice—in July 2025 and early 2026—because the single-arm IGNYTE study lacked a control group. A coalition of melanoma physicians and patient advocates lobbied for access, and the advisory panel ultimately voted in favor of approval. The therapy infects injected tumors, causes cell lysis, and stimulates a systemic immune response that can restore sensitivity to PD-1 blockade.

Medscape

• Objective response rate: 24.2 % (91 evaluable patients)

Medscape

• Median duration of response: 14.1 months

Medscape

• Serious adverse reactions: 35 % of treated patients

Medscape

• List price: $450,000 per treatment course (Reuters; Medscape)

BioSpace

• Target patient pool: roughly 10,000 annual advanced-melanoma cases in the United States, with early-adopter accounts aimed at 30 % of this population

BioSpace

FDA acting director Karim Mikhail emphasized the urgent need for new options in PD-1-refractory melanoma, noting that “the prognosis is often devastating.” CFO Emily Hill said the product can be shipped within about 60 days of approval and that the company is expanding its commercial team for launch.

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• Sales forecasts: Reuters projects $708 million in peak U.S. sales, while Biopharmadive cites $618 million; Wall Street consensus approaches $1 billion.

BioPharmaDive

• Confirmatory trial timeline: Reuters expects data from the ongoing confirmatory study in 2030; Biopharmadive indicates results are anticipated in late 2027. The exact timing of the pivotal readout remains uncertain.

Replimune's Conditional Comeback: FDA Approval Ends a Bruising Regulatory Chapter

• Methodological concerns: FDA reviewers criticized the single-arm design, but a majority of advisory-panel experts argued the observed signal justified approval.

Medscape

• “With no compelling and widely accessible option in PD-1 relapsed melanoma, and a relatively benign safety profile for RP1 + nivolumab, we expect real commercial uptake for RP1,” — Leerink Partners

Reuters

• “We are incredibly grateful to those internally and externally who fought so hard for patient access to this innovative and important therapy,” — CEO Sushil Patel

BioSpace

Replimune is enrolling patients in the Phase 3 IGNYTE-3 trial, which compares the Tudriqev-nivolumab regimen against PD-1 inhibitors or chemotherapy. Top-line results are expected either in late 2027 or by 2030, depending on the reporting schedule. The company plans a staged launch, targeting 200 early-adopter sites in the first six months and expanding to roughly 1,200 sites within a year. Confirmation of clinical benefit will be required to maintain the accelerated-approval status.

BioPharmaDive