FDA granted accelerated approval for Tudriqev, previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.

The indication’s approval is based on objective response rate and duration of response, and continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial or trials.¹ Tudriqev is administered via direct intratumor injection into superficial, deep, and visceral lesions, with imaging technology guiding administration for deep or visceral tumors. The recommended dose is based on tumor size.

What did the Ignyte trial show?

The Ignyte trial enrolled 140 patients, with 91 patients who had at least one non-injected lesion included in the efficacy-evaluable population. In this population, Tudriqev plus nivolumab achieved an objective response rate of 24.2%, with a median duration of response of 14.1 months.² The patient population included those with Stage 4 disease (80%), prior anti-PD-1 adjuvant treatment (13%), PD-L1 negative status (54%), lung lesions (45%), and liver lesions (24%).² 

Recently, FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 10 to 3 that the efficacy results from the Ignyte study were evaluable and clinically meaningful, marking a significant step in the approval process.

Treatment with Tudriqev plus nivolumab was well tolerated, with mostly mild-to-moderate adverse events. The most common adverse reactions, occurring in at least 10% of patients, were nausea, diarrhea, vomiting, constipation, decreased appetite, abdominal pain, fatigue, pyrexia, chills, injection site reaction, influenza-like illness, infections, musculoskeletal pain, arthralgia, headache, dizziness, cough, dyspnea, rash, pruritus, and hemorrhage.² Most treatment-related adverse reactions were grade 1 and 2 and transient, and there were no grade 4 or 5 common adverse events.

Why does this approval matter?

There are limited treatment options for advanced melanoma, and more than half of patients experience progression within six months of treatment on immune checkpoint inhibitors like anti-PD-1 therapy. These patients face a poor prognosis, with a median overall survival of less than one year following progression.

"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," said Sushil Patel, Ph.D., chief executive officer of Replimune. "We are deeply grateful to the melanoma community, including patients and investigators who participated in the clinical trial, for their tremendous support of this approval. We also would like to thank FDA for recognizing the urgency to get this therapy to patients. Replimune is now focused on critical activities to deliver Tudriqev to as many patients as possible."

How did we get here?

The approval caps a bumpy, nearly two-year regulatory path for RP1. Replimune first submitted a biologics license application for the therapy on November 22, 2024, built on the single-arm Ignyte study. FDA rejected that application on July 21, 2025, issuing a complete response letter that concluded the trial did not provide substantial evidence of effectiveness, in part because of heterogeneity within the studied patient population.

Replimune resubmitted the application, and FDA accepted that resubmission with a target decision date of April 10, 2026. But FDA issued a second complete response letter in April 2026, again citing unresolved questions about whether the Ignyte data adequately demonstrated RP1's contribution of effect when paired with nivolumab.

Replimune pressed ahead with a third resubmission, which FDA accepted with a new target decision date of August 2, 2026. An FDA advisory committee then took up the application, and despite agency staff raising concerns about the design and conduct of the Ignyte trial, the panel voted in support of the therapy, concluding the efficacy signal was strong enough and that patients had an urgent unmet need. FDA granted accelerated approval on August 6, 2026, four days after its target decision date, clearing RP1 for market as Tudriqev after twice rejecting it.

What comes next?

To verify the clinical benefit of Tudriqev, a confirmatory Phase III trial, Ignyte-3, is ongoing and assessing Tudriqev in combination with nivolumab.¹ Ignyte is an open-label, multicenter Phase I/II study evaluating the safety and efficacy of vusolimogene oderparepvec as monotherapy or in combination with nivolumab in adult patients with advanced solid tumors.¹

Sources

1. Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen Replimune August 6, 2026, https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
2. VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3] National Library of Medicine July, 15, 2026, https://clinicaltrials.gov/study/NCT06264180