FDA Grants Accelerated Approval to Replimune's Tudriqev Plus Nivolumab for Advanced Melanoma

FDA has granted accelerated approval to Replimune's vusolimogene oderparepvec-wtpg (Tudriqev), in combination with nivolumab, for adults with unresectable advanced cutaneous melanoma who progressed on an anti-programmed cell death protein 1 (PD-1)-based regimen, the company announced August 6, 2026.¹ The approval follows 2 prior complete response letters (CRLs) for the therapy, previously known as RP1, in July 2025² and April 2026,³ and a July 30, 2026, FDA advisory committee vote (10-3) affirming that the drug's efficacy data were evaluable and clinically meaningful.⁴ Approval is based on objective response rate and duration of response, and continued approval may depend on verification of clinical benefit in a confirmatory trial.¹

"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, PhD, CEO of Replimune, in a company press release.¹

What did the IGNYTE trial show?

The pivotal IGNYTE trial (NCT03767348) enrolled 140 patients, with 91 patients who had at least one non-injected lesion included in the efficacy-evaluable population. In that population, vusolimogene oderparepvec-wtpg plus nivolumab achieved an objective response rate of 24.2%, with a median duration of response of 14.1 months.¹

The patient population included 80% with stage 4 disease, 13% with prior anti-PD-1 adjuvant treatment, and 54% with PD-L1-negative status. Treatment was generally well tolerated, with mostly mild-to-moderate adverse events and no grade 4 or 5 common adverse events; serious adverse reactions occurred in 35% of patients, and 2.9% discontinued treatment permanently due to adverse reactions. Trial data were published in the Journal of Clinical Oncology.¹

How did this application clear FDA after 2 rejections?

Replimune's path to approval included two earlier setbacks. FDA issued a first CRL in July 2025 and a second in April 2026, both citing concerns that the single-arm IGNYTE design did not provide substantial evidence of effectiveness.^2,3 Replimune resubmitted a 3rd time, and FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 on July 30, 2026 that the IGNYTE efficacy results were evaluable and clinically meaningful, days after the company's shares had dropped nearly 32% amid regulatory uncertainty.⁵ The company's stock surged more than 120% following the favorable committee vote.⁶

What's next for confirming the drug's benefit?

To verify clinical benefit, Replimune is running a confirmatory phase 3 trial, IGNYTE-3 (NCT06264180), evaluating vusolimogene oderparepvec-wtpg plus nivolumab. The company has also launched ReplimuneConnect Plus, a patient support program covering access, reimbursement, and financial assistance.¹

What are the limitations?

Accelerated approval does not necessarily guarantee the therapy retains its indication. Continued marketing is contingent on IGNYTE-3 confirming clinical benefit. The efficacy population (91 of 140 enrolled patients) reflects a subset with non-injected lesions, and the single-arm trial design was the basis for FDA's two earlier rejections before this approval.

References

1. Replimune Group. Replimune announces FDA accelerated approval of TUDRIQEV in combination with nivolumab for unresectable advanced cutaneous melanoma after progression on an anti-PD-1 based regimen. Press release. Published August 6, 2026. Accessed August 7, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
2. Replimune Group. Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma. Press Release. Published July 22, 2025. Accessed August 7, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics/
3. Replimune Group. Replimune receives complete response letter from the FDA for RP1 biologics license application for the treatment of advanced melanoma. Press Release. Published April 10, 2026. Accessed August 7, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics-0
4. Replimune Group. Replimune announces favorable outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee meeting for RP1 in advanced melanoma. Press release. Published July 30, 2026. Accessed Aug. 7, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-favorable-outcome-fdas-cellular-tissue-and
5. Paul A. FDA Staff Raise Concerns On Replimune’s Skin Cancer Drug – REPL Stock Crashes 32% Today Ahead Of Advisory Meeting This Week. Yahoo Finance. July 28, 2026. Accessed August 7, 2026. https://finance.yahoo.com/healthcare/articles/fda-staff-raise-concerns-replimune-145512447.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAGL4IO2QD5GBfXSk48MWTERNenfGe-gH2ZOAOs4ZdJu8RV-G9GSLFqyzcuzOZvHjQgTxi6VEsr55YM9pwFr-7xMZrXjodRwW83ANbC8QXQhLiuGSfw6awaDkLt34LrIfXh_GhFqW7UN_RyB71OLPvvvj0VsQwUfMl_3ZkAzMlCP3
6. Santhosh, C. Replimune surges after FDA advisers back skin cancer drug. Reuters. July 31, 2026. Accessed August 7, 2026. https://www.reuters.com/legal/litigation/replimune-surges-after-fda-advisers-back-skin-cancer-drug-2026-07-31/