FDA approves new oncolytic viral therapy for anti‑PD‑1‑refractory melanoma

The U.S. Food and Drug Administration granted accelerated approval to RP1 (vusolimogene oderparepvec), marketed as Tudriqev, in combination with the anti‑PD‑1 antibody nivolumab. The indication is for adult patients with unresectable or metastatic cutaneous melanoma that has progressed after prior anti‑PD‑1 therapy. The decision was based on trial data showing an objective response in roughly one‑quarter of patients, with responses lasting a median of about 14 months, providing a new treatment option for a population with limited alternatives. Tudriqev is a genetically engineered oncolytic herpes simplex virus designed to replicate within tumor cells, lyse them, and stimulate a systemic immune response. The FDA’s accelerated approval requires the sponsor to complete post‑marketing studies to confirm clinical benefit. Expert and patient‑advocate input highlighted the urgent need for effective therapies in this refractory setting.