Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections

Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough effectiveness to merit approval.

The panel reviewed data from a trial that combined RP1 with Bristol Myers Squibb's Opdivo in patients with advanced melanoma. While members agreed the study had significant methodological issues, they observed tumor shrinkage in both injected and non‑injected lesions, offering clinical benefit to patients with few options.

A majority of the experts supported approval, noting the observed tumor reductions and potential benefit. Dr. Hussein Tawbi of MD Anderson highlighted that the shrinking tumors translated into real clinical advantage for patients.

Three members voted against approval, citing lingering uncertainty over the trial design and the need for clearer data from the ongoing phase 3 study before a final decision can be made.