Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma

The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug.

The therapy, previously identified as RP1 and to be sold under the name Tudriqev, is intended for use together with Bristol Myers Squibb's Opdivo in patients whose disease has progressed following PD‑1 inhibitor therapy.

Tudriqev is an engineered oncolytic virus that is injected directly into tumors, where it replicates, destroys cancer cells and releases immune‑stimulating proteins.

The approval is accelerated, meaning the drug will remain on the market only if a Phase 3 trial confirms its benefit. That study, comparing the Tudriqev‑Opdivo combo to standard PD‑1 drugs or chemotherapy, is slated to report results in late 2027.

In a single‑arm trial that supported the decision, roughly one‑quarter of participants experienced a measurable tumor response.