The US FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy developed by Massachusetts-based Replimune, Inc. (Nasdaq: REPL), for adult patients with unresectable advanced cutaneous melanoma whose disease progressed on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. Tudriqev is administered in combination with nivolumab (Opdivo), Bristol Myers Squibb's anti-PD-1 checkpoint inhibitor. The approval marks the first oncolytic viral therapy approved specifically for anti-PD-1 refractory melanoma and arrives after a protracted regulatory path that included two Complete Response Letters and a BLA resubmission following FDA alignment discussions.
Tudriqev is administered by intratumoral injection once every two weeks for eight consecutive doses, with dose concentration escalating after the first injection. Nivolumab is introduced intravenously beginning at week three. The application held Breakthrough Therapy and Priority Review designations. As a condition of accelerated approval, Replimune is required to conduct confirmatory trial(s) to verify clinical benefit; continued approval may be contingent on those results.
Efficacy was evaluated in an open-label, multiregional, single-arm trial enrolling 140 adult patients with Stage IIIB, IIIC, or IV unresectable advanced melanoma who had progressed on at least eight consecutive weeks of prior anti-PD-1-based therapy. Of 91 evaluable patients, 24% achieved an objective response, with a median response duration of 14.1 months. The FDA's advisory committee voted 10–3 on July 30, 2026 in favor of the clinical meaningfulness of the IGNYTE trial data, a vote that preceded the approval by one week. The FDA had previously raised efficacy concerns about the single-arm study design in its pre-advisory committee briefing document.
Tudriqev is based on an engineered herpes simplex virus type 1 (HSV-1) that selectively replicates within and lyses tumor cells, releasing tumor-associated antigens and triggering innate and adaptive immune activation. Combined with nivolumab, the therapy is intended to restore antitumor immune responses in patients whose tumors had become refractory to checkpoint inhibition. Safety warnings include risk of herpes transmission to close contacts, herpes reactivation in the patient, and injection procedure-related complications.