FDA Approves Replimune’s Oncolytic Virus Immunotherapy for Advanced Melanoma

Sep 10 , 2026
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Sep 10, 2026 —

The U.S. Food and Drug Administration (FDA) has approved Tudriqev (vusolimogene oderparepvec), an oncolytic virus immunotherapy from Replimune, for patients with unresectable advanced melanoma whose disease has progressed after PD-1 immunotherapy.

Formerly known as RP1, the therapy is an engineered, live-attenuated herpes simplex virus type 1 (HSV-1) designed to selectively infect and destroy cancer cells while stimulating an immune response; it encodes GM-CSF and a fusogenic glycoprotein. It is only the second oncolytic virus therapy to be approved, after Amgen’s Imlygic (talimogene laherparepvec), also in advanced melanoma.

Oncolytic viruses are a small but distinct branch of engineered-virus therapeutics, using the virus itself as the treatment.

Source:

https://www.nature.com/articles/s41587-026-03316-9

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