FDA Approves Engineered Viral Immunotherapy for Advanced Melanoma

The Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev), a genetically modified oncolytic viral therapy, for adults with unresectable advanced cutaneous melanoma that has progressed following treatment with a PD-1-blocking antibody. The therapy is administered in combination with nivolumab.

Vusolimogene oderparepvec is based on a modified herpes simplex virus type 1 (HSV-1) engineered to selectively target and destroy cancer cells. When injected directly into tumors, the virus replicates within cancer cells and triggers an immune response against the tumor.

The agency approved the therapy in response to results from an open-label, multiregional, single-arm clinical trial involving 140 adults with Stage IIIB, IIIC or IV unresectable advanced melanoma. Among 91 patients evaluated for efficacy, 24% achieved an objective response, with a median response duration of 14.1 months.

Vusolimogene oderparepvec-wtpg is administered by intratumoral injection once every two weeks for eight doses. Nivolumab is administered intravenously beginning at week three.

FDA noted that important safety warnings include the potential for accidental transmission of herpes infection to close contacts, development or reactivation of herpes infection in patients, and complications associated with the injection procedure.

The application received Breakthrough Therapy and Priority Review designations. Because the approval was granted through the accelerated approval pathway based on objective response rate and duration of response, the manufacturer, Replimune Inc., is required to conduct post-approval studies to verify and describe the therapy’s clinical benefit.