FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections

The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma.

An advisory committee voted in favor of the drug despite FDA staff raising concerns about the design and conduct of the pivotal trial. The committee concluded that the efficacy signal was sufficient and that patients urgently need new options.

The approval reverses two earlier rejections, delivering a major win for Replimune and the patient‑advocacy groups that have supported the therapy. The company has not yet disclosed pricing for Tudriqev.