Replimune’s Tudriqev immunotherapy receives FDA accelerated approval for advanced melanoma

Replimune announced that the FDA granted accelerated approval for its immunotherapy, now branded Tudriqev, in combination with Bristol Myers Squibb’s Opdivo. The decision follows two earlier rejections and marks the end of a lengthy regulatory effort.

The approval applies to adults with advanced melanoma who have progressed after anti‑PD‑1 antibody therapy. The agency based its decision on the drug’s objective response rate and the duration of those responses observed in clinical studies.

An FDA advisory committee voted 10‑3 in favor of the therapy, reflecting strong backing from oncologists. The product, previously known as vusolimogene oderparepvec‑wtpg and RP1, will be marketed under the Tudriqev name.

Replimune noted that continued marketing approval may hinge on confirmatory trials that verify clinical benefit, and the company’s CEO called the milestone a transformative moment for patients in need of new treatment options.