After Wild Ride, FDA Grants Accelerated Approval for Replimune’s RP1 Plus Nivolumab in Advanced Melanoma

FDA today granted accelerated approval for Replimune Group’s RP1 (vusolimogene oderparepvec), to be sold as Tudriqev, a novel oncolytic immunotherapy combined with nivolumab to treat adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.¹ Company officials said in a statement that continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial.

The move signals a reversal of fortune for the therapy, following a tumultuous regulatory path that included 2 complete response letters and a thumbs down from the FDA staff ahead of a July 30, 2026, advisory panel vote.^2,3

However, the Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 to recommend approval for the therapy, following what one analyst called “overwhelming testimony from melanoma physicians, patients, and patient advocates.”³

The vote to recommend RP1 with nivolumab was based on data from the IGNYTE clinical trial, which evaluated the combination in patients with confirmed progression on an anti-PD-1 containing regimen.⁴ It comes 4 days after the August 2, 2026, target date for action under the Prescription Drug User Fee Act, which fell on a Sunday.

Melanoma is the fifth most common cancer in the US, affecting about 112,000 patients this year and accounting fornearly 8500 deaths annually.⁵ Although melanoma was the earliest cancer successfully treated with immune checkpont inhibitors, about half of patients will not respond or will see their cancer progress. Thus, a significant unmet need exists for patients whose melanoma has spread beyond the primary tumor.

According to Replimune, RP1 is based on a strain of herpes simplex virus that has been re-engineered with fusogenic protein, called GALV, and granulocyte-macrophage colony-stimulating factor (GM-CSF), which are designed to dramatically increase its potency while also boosting anti-tumor immune response. However, it works in a targeted manner, leaving healthy cells intact.⁶ 

Data from IGNYTE show that among 140 patients enrolled, confirmed overall response rate was 32.9%, with a median duration of response of 33.7 months. Overall survival rates at 1 and 2 years were 75.3% (95% CI, 66.9% to 81.9%) and 63.3% (95% CI, 53.6% to 71.5%), respectively. Biomarker analysis demonstrated broad immune activation associated with response, and treatment-related adverse event rates were 77.1% grade 1/2, 9.3% grade 3, 3.6% grade 4, and no grade 5 events.⁴

“Advanced melanoma patients have few options after anti-PD-1 therapy and face high morbidity and poor survival outcomes,” Michael K. Wong, MD, PhD, primary investigator of the IGNYTE study and former physician in chief and professor of oncology at Roswell Park Comprehensive Cancer Center in Buffalo, New York, said in the statement.¹

“With the approval of Tudriquev, we have a potent oncolytic immunotherapy that can be used in a broad population, including BRAF-naïve or pretreated, and adjuvant relapsed patients. Importantly, the therapy in combination with nivolumab drives immune activation with a favorable risk-benefit profile and can be injected into superficial and visceral lesions.”¹

References

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. News release. Replimune. August 6, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
2. Replimune receives complete response letter from the FDA for RP1 Biologics License Application for the yreatment of advanced melanoma. News release. Replimune. April 10, 2026. Accessed July 24, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics-0
3. Santhosh C.Replimune surges after FDA advisers back skin cancer drug. Reuters. July 31, 2026. Accessed July 31, 2026. https/www.reuters.com/legal/litigation/replimune-surges-after-fda-advisers-back-skin-cancer-drug-2026-07-31/
4. Wong MK, Milhem MM, Sacco JJ, et al. RP1 combined with nivolumab in advanced anti-PD-1-failed melanoma (IGNYTE). J Clin Oncol. 2025;43(33):3589-3599. doi: 10.1200/JCO-25-01346
5. Levy J. Over 112,000 Americans estimated to be diagnosed with invasive melanoma in 2026. Melanoma Research Alliance. January 23, 2026.Accessed July 24, 2026. https://www.curemelanoma.org/blog/over-112-000-americans-estimated-to-be-diagnosed-with-invasive-melanoma-in-2026
6. Replimune announces FDA acceptance of RP1 Biologics License Application resubmission for advanced melanoma. News release. Replimune. June 26, 2026. Accessed July 24, 2026. https://ir.replimune.com/node/11376/pdf