The FDA granted Tudriqev an “accelerated” approval, meaning continued licensure is contingent on the success of an ongoing Phase 3 trial. In briefing documents ahead of an advisory panel last week, FDA reviewers challenged those findings, arguing the way Replimune designed its trial and measured responses made distinguishing Tudriqev’s true impact difficult. “For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. The approval provides a much-needed lifeline for Replimune, which has warned that it might have to scrap development of Tudriqev if the therapy was turned back yet again. Tudriqev has been swept up in the turmoil engulfing the FDA for much of the last year or so.