FDA Approves Tudriqev Plus Nivolumab for Advanced Melanoma
Key Takeaways
- The FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), an engineered oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed after anti–PD-1 therapy.
- In the efficacy population, 24% of patients achieved an objective response, with a median response duration of 14.1 months.
- The approval is based on response rate and durability, with continued approval dependent on confirmation of clinical benefit post-approval.
The FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg; Replimune, Inc.) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on a programmed death receptor-1 (PD-1)–blocking antibody-based regimen, according to a press release from the U.S. Food and Drug Administration (FDA).
Engineered Oncolytic Virus Targets PD-1–Refractory Melanoma
Tudriqev, administered by intratumoral injection, is a genetically modified oncolytic therapy based on herpes simplex virus type 1 (HSV-1). The therapy, according to the press statement, is engineered to replicate within and destroy tumor cells while stimulating an antitumor immune response. Nivolumab, an anti–PD-1 therapy, is administered intravenously beginning during the treatment course. The FDA announced that it based the accelerated approval (and Breakthrough Therapy and Priority Review designations) on the therapy's open-label, multiregional, single-arm trial of 140 adults with stage IIIB, IIIC, or IV unresectable melanoma whose disease had progressed after at least 8 consecutive weeks of anti–PD-1–based therapy. Among 91 patients evaluated for efficacy, the objective response rate was 24%, with a median duration of response of 14.1 months.
Common adverse reactions occurring in more than 10% of patients included fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection-site reactions, headache, rash, and influenza-like illness, among others. Safety warnings include potential herpes infection or reactivation, accidental transmission to close contacts, and injection-related complications.
“For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited,” Karim Mikhail, BPharm, MS, acting director of the FDA’s Center for Biologics Evaluation and Research, said in the news release. “Today’s important milestone gives oncologists a meaningful new tool — and more patients a fighting chance.”
Source
FDA news release. August 7, 2026.