Tudriqev Approved for Advanced Melanoma
On Aug. 6, 2026, Replimune’s Tudriqev™ (vusolimogene oderparepvec-wtpg) received accelerated approval from the US Food and Drug Administration (FDA) for use in combination with Opdivo® (nivolumab – Bristol Myers Squibb) for the treatment of adults with unresectable advanced cutaneous melanoma who have experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. Tudriqev is a genetically modified oncolytic viral therapy based on herpes simplex virus type 1 (HSV-1) that is designed to selectively infect and destroy tumor cells while stimulating an antitumor immune response. The recommended regimen consists of eight intratumoral injections administered every two weeks, with the first dose given at a concentration of 106 plaque-forming units (PFU)/mL and subsequent doses at 107 PFU/mL. Replimune plans to begin shipping Tudriqev in approximately 60 days. The company estimates the treatment course will cost approximately $450,000, although costs may vary based on the volume administered. Full prescribing information can be found here.
At a Glance
- Brand Drug: Tudriqev™ (vusolimogene oderparepvec-wtpg)
- Manufacturer: Replimune
- Date Approved: Aug. 6, 2026
- Indication: For use in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who have experienced disease progression on a PD-1-blocking antibody-based regimen
- Dosage Forms Available: single-dose vials containing 106 PFU/mL and 107 PFU/mL for intratumoral injection
- Launch Date: Early October
- Estimated Annual Cost: Approximately $450,000 for the treatment course
- FDA Designation: Breakthrough Therapy. Priority Review. Accelerated Approval.
- Melanoma accounts for the majority of skin cancer-related deaths. In 2026, approximately 112,000 Americans are expected to be diagnosed with invasive melanoma and about 8,500 are expected to die from the disease.
- Replimune estimates that approximately 9,000 patients annually in the US may be eligible for therapy.
- Approval was based on results from the phase I/II IGNYTE trial. Among 91 efficacy-evaluable patients with at least one non-injected lesion, Tudriqev plus nivolumab demonstrated an objective response rate (ORR) of 24.2% and a median duration of response of 14.1 months.
- On July 30, 2026, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy data from the IGNYTE trial supported a clinically meaningful treatment effect, despite FDA reviewer concerns regarding the lack of a comparator arm and uncertainty about the contribution of Tudriqev to observed outcomes when used in combination with nivolumab.
- The approval was granted under FDA’s accelerated approval pathway based on the ORR and duration of response. Continued approval may be contingent upon verification of clinical benefit in the ongoing phase III IGNYTE-3 trial, with data expected in 2030.
- Tudriqev is expected to compete primarily with Amtagvi™ (lifileucel – Iovance Biotherapeutics), a tumor-infiltrating lymphocyte (TIL) cell therapy approved for unresectable or metastatic melanoma following progression on prior immunotherapy. Additional treatment options in advanced melanoma include immune checkpoint inhibitor regimens such as Opdivo with Yervoy® (ipilimumab – BMS) or Keytruda® (pembrolizumab) or Opdualag™ (nivolumab/relatlimab – BMS).