Replimune Tudriqev Approved: First Oncolytic Virus for Melanoma After Two CRLs

The FDA granted accelerated approval to Replimune’s (REPL) Tudriqev (vusolimogene oderparepvec-wtpg, formerly RP1) on August 6, clearing the oncolytic viral immunotherapy for use with Bristol Myers Squibb’s Opdivo (nivolumab) in adults with unresectable advanced cutaneous melanoma who progressed on an anti-PD-1 regimen. It is the first oncolytic virus approved for melanoma and the first engineered herpes simplex virus product cleared for any solid tumor indication. Replimune shares closed at $12.86 on August 6, up roughly 9% from the $11.83 prior close.

The approval arrives on the company’s third attempt. The FDA issued Complete Response Letters in July 2025 and April 2026, both centered on whether the single-arm IGNYTE study could reliably distinguish Tudriqev’s contribution from nivolumab alone. Last week’s 10-3 Cellular, Tissue and Gene Therapies Advisory Committee vote, after briefing documents that called the IGNYTE data “not interpretable,” appeared to settle the question for a majority of panelists.

The IGNYTE registrational cohort enrolled 140 patients with confirmed progression on at least eight weeks of anti-PD-1 therapy. In the 91-patient efficacy-evaluable population (those with at least one non-injected lesion), Tudriqev plus nivolumab produced an objective response rate of 24.2% with a median duration of response of 14.1 months. The population was high-risk: 80% had Stage 4 disease, 54% were PD-L1 negative, and roughly a quarter had liver metastases, the strongest negative prognostic factor in melanoma. Treatment was well tolerated with mostly Grade 1-2 adverse events and no Grade 4 or 5 treatment-related events. The confirmatory Phase 3 IGNYTE-3 trial, randomizing Tudriqev plus nivolumab against physician’s choice (over 90% receiving Opdualag, BMS’s relatlimab-nivolumab combination), is already underway.

The regulatory history explains why this approval matters beyond the indication. After two CRLs over trial-design concerns, the FDA’s willingness to grant accelerated approval on a third review signals that the agency accepted the evidentiary package it had twice rejected, and that the 10-3 AdComm vote carried real weight despite the committee’s skepticism about IGNYTE’s single-arm structure. The approval carries the standard accelerated-approval condition: continued marketing depends on verification of clinical benefit in the confirmatory IGNYTE-3 trial, with results expected in 2027.

Replimune becomes a commercial-stage company for the first time. The question shifts from regulatory survival to launch execution: building a sales force, securing formulary access, and training interventional radiologists on ultrasound-guided deep visceral injections. The broad label, covering all advanced melanoma patients post-anti-PD-1 regardless of BRAF status or prior adjuvant therapy, gives the company a large addressable population. Roughly half of the estimated 105,000 new U.S. melanoma cases annually will progress on or after checkpoint inhibitor therapy.

What to watch next: the IGNYTE-3 readout. If the confirmatory trial hits its endpoint, accelerated approval converts to full approval and Tudriqev becomes a permanent fixture in the melanoma treatment sequence. If it misses, the accelerated approval is at risk. The commercial launch (pricing, payer coverage, and early uptake in the anti-PD-1 refractory niche) will provide the first real-world signal on whether the oncolytic virus platform can generate revenue beyond a token approval.

Replimune press release