What happened?
The FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev) with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed after PD-1-directed therapy. Approval was based on objective response rate and duration of response.
Why does it matter?
Oncolytic viruses are designed to act inside tumours while also stimulating anti-tumour immunity. The approval is important because patients progressing after PD-1 blockade need effective salvage strategies.
How to interpret the evidence
Because this is accelerated approval, post-approval trials must verify clinical benefit. Response rate is clinically meaningful, but it is not the same endpoint as overall survival.
What remains uncertain?
This is not a new first-line treatment for all melanoma and it does not replace surgery or standard treatment of early-stage disease.
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