FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
Full prescribing information for Tudriqev will be posted on Drugs@FDA.
On July 30, 2026, the FDA convened the Cellular, Tissue, and Gene Therapies Advisory Committee Meeting to discuss this application. The meeting included a public hearing section to hear from patients, patient advocates, clinicians and independent experts, followed by a session for discussion and deliberation among committee members.
The approval was granted under the FDA's accelerated approval pathway based on objective response rate and duration of response. As a condition of accelerated approval, Replimune, Inc., is required to conduct post-approval trial(s) to verify and describe the clinical benefit of Tudriqev in combination with nivolumab. Continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s).
Safety and Efficacy
The safety and efficacy of Tudriqev were evaluated in IGNYTE (NCT03767348), an open-label, multiregional, single-arm trial in 140 adult patients with Stage IIIB, IIIC or IV unresectable advanced melanoma who experienced disease progression on at least eight consecutive weeks of prior anti-PD-1-based therapy. Of the 140 patients, 91 patients with at least one noninjected lesion were included in the efficacy-evaluable population.
The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR). ORR was 24.2% (15.8, 34.3) and the median DOR was 14.1 months (10.7, not reached).
The prescribing information includes warnings and precautions for accidental exposure, herpetic infection or reactivation, injection procedure complications, and immune-mediated events. Most common non-laboratory adverse reactions reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.
Recommended Dosage
The recommended dosage of vusolimogene oderparepvec-wtpg is 1 mL/cm of the largest dimension of the tumor, for a maximum of 10 mL across all lesions treated per dose. The size of each injectable lesion should be assessed on each treatment day to determine the required vusolimogene oderparepvec-wtpg volume. If multiple tumors are present, clinicians should prioritize the most rapidly growing and largest new or existing lesions suitable for injection. Intratumoral injections of vusolimogene oderparepvec-wtpg should be administered every two weeks for eight consecutive doses, beginning at a concentration of 10⁶ plaque-forming units (PFU) per mL at Week 1, followed by 10⁷ PFU per mL for subsequent doses.
Nivolumab should be administered intravenously starting at Week 3, according to the nivolumab prescribing information. See the full prescribing information for preparation and administration instructions.
Vusolimogene oderparepvec-wtpg in combination with nivolumab was granted breakthrough therapy designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov .