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
Key facts
- Drug: vusolimogene oderparepvec-wtpg (Tudriqev; Replimune)
- Class: Oncolytic HSV-1 immunotherapy (formerly RP1)
- Indication: Unresectable advanced cutaneous melanoma, post-anti-PD-1
- Trial: IGNYTE (NCT03767348); phase 1/2, registrational cohort
- Primary endpoint met: ORR 24.2%; median DOR 14.1 months
- Safety: 35% serious adverse reactions; no grade 4/5 events
- Regulatory status: Accelerated approval granted August 6, 2026 (3rd submission)
- Prior setbacks: CRLs in July 2025 and April 2026
- Confirmatory trial: IGNYTE-3 (NCT06264180), ongoing
- Geography: US approval; combination with nivolumab
"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
