09/12/2026
FDA Approves Drug to Treat Treatment-Resistant Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has approved a new drug to treat adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. Tudriqev (vusolimogene oderparepvec-wtpg) is a genetically modified oncolytic viral therapy 12 indicated in combination with nivolumab administered as a suspension for intratumor injection.
The safety and efficacy of Tudriqev (vusolimogene oderparepvec-wtpg) were evaluated in an open-label, multiregional, single-arm trial enrolling 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. The primary efficacy outcome was objective response rate (ORR), and the secondary outcome 464 measure was duration of response (DOR). In the trial, 91 patients were evaluated, and 24% of patients achieved an objective response. Responses had a median duration of 14.1 months.
Warnings and precautions for Tudriqev (vusolimogene oderparepvec-wtpg) include accidental exposure to Tudriqev (vusolimogene oderparepvec-wtpg), herpetic infection or reactivation, injection procedure complications, including but not limited to 46 hemorrhage, infection, and visceral injury, and Immune-mediated events. The most common adverse reactions (incidence > 10%) are 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.
View the FDA’s announcement here:
https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma
