FDA approves second oncolytic virus for advanced melanoma
Now Possible · Friday, 11 September 2026
Why it matters
This is a clear move from demonstrated therapy to regulated clinical availability, but not yet evidence of broad everyday accessibility: eligibility is restricted to advanced melanoma after prior PD-1 treatment, and no cost or delivery information is provided.
What happened
The FDA approved Replimune’s Tudriqev (vusolimogene oderparepvec, formerly RP1) in August 2026 for unresectable advanced melanoma that has progressed after PD-1 immunotherapy. The engineered HSV-1-based therapy is only the second oncolytic virus approved in the United States, after Amgen’s Imlygic for a related advanced skin-cancer indication. The approval establishes an authorized treatment option for this narrowly defined group, but the available report provides no information on price, supply, treatment sites, or practical access outside specialist oncology care.
Previously
Apr 2026 — The FDA issued Replimune a Complete Response Letter concerning the application for TUDRIQEV, formerly known as RP1.(Globhy)
Jul 2025 — The FDA issued Replimune a Complete Response Letter concerning the application for TUDRIQEV, formerly known as RP1.(Globhy)
Players & places
- United States
- US Food and Drug Administration
- Replimune
- Amgen