FDA Grants Accelerated Approval to Replimune’s Tudriqev for Advanced Melanoma

The U.S. Food and Drug Administration issued an accelerated approval for Replimune’s oncolytic virus therapy, marketed as Tudriqev (vusolimogene oderparepvec), in combination with Bristol Myers Squibb’s Opdivo (nivolumab). The decision applies to adults with unresectable advanced cutaneous melanoma whose disease progressed after anti-PD-1 therapy. The approval follows a July 30 advisory-committee vote of 10-3 that the IGNYTE trial data were evaluable and demonstrated clinically meaningful benefit; it was announced publicly on August 6.

PharmaphorumMedscapeBioSpaceBioPharmaDiveReuters

Tudriqev, formerly RP1, is a genetically modified herpes simplex virus that replicates in injected tumors, lyses cancer cells, and stimulates systemic immunity. Replimune first sought approval in July 2025 but received a complete response letter rejecting the single-arm IGNYTE study for lacking a control group. A second rejection arrived in April 2026. After the July 30 advisory-committee meeting, the agency reversed course and granted accelerated approval, contingent on a confirmatory trial.

Medscape

• Objective response rate (ORR): 24.2% (Reuters; Medscape).

Medscape

• Median duration of response: 14.1 months (Reuters; Medscape).

Medscape

• Trial size: 140 patients enrolled; 91 evaluated for efficacy.

Medscape

• Safety: Serious adverse reactions in 35% of participants; most common were fatigue, fever, infection, chills, musculoskeletal pain, and nausea.

Medscape

• Pricing: Approximately $450,000 per treatment course.

Pharmaphorum

• Sales forecasts: Peak U.S. sales projected near $1 billion (Leerink Partners); $708 million by 2040 (Cantor Fitzgerald).

Pharmaphorum

Replimune’s CEO Sushil Patel called the approval a “transformative moment” that validates years of research. The accelerated-approval pathway ties continued marketing to positive results from an ongoing confirmatory trial, with data expected in 2030.

BioSpace

• Response rate: Reuters and Medscape report a 24.2% ORR, while Pharmaphorum cites 34% from the same IGNYTE study.

Medscape

• Duration of response: Reported medians differ between 14.1 months (Reuters, Medscape) and 24.8 months (Pharmaphorum).

Medscape

• Interpretability: FDA reviewers questioned the single-arm design, whereas advisory-committee members deemed the data “clinically meaningful,” highlighting a gap in consensus on efficacy assessment without a control arm.

BioSpace

• “For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited,” — Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research

Pharmaphorum

• “This is a transformative moment for Replimune, marking years of pioneering research to bring Tudriqev to patients desperately in need of new treatment options for advanced melanoma,” — Replimune CEO Sushil Patel

BioSpace

Replimune must complete a confirmatory late-stage study (IGNYTE-3) to verify clinical benefit; results are slated for 2030. The company plans to launch Tudriqev within the next few months, keeping the price near $450,000 per course, below the $563,000 price of the competing T-cell therapy Amtagvi. Ongoing safety monitoring and real-world effectiveness data will determine the therapy’s long-term market presence.

Pharmaphorum