Replimune’s oncolytic viral therapy Tudriqev has won FDA accelerated approval for advanced melanoma, completing a fast-moving regulatory turnaround after the program was rejected previously and resubmitted. The approval sets Tudriqev up as a more convenient option in the setting where cell therapy—most notably Iovance’s approach—has previously dominated. The FDA decision followed a sequence that included an earlier rejection, then an advisory committee vote and a resubmission that progressed quickly to approval. Tudriqev is positioned around practical administration advantages relative to cell-based therapies, an operational factor that can influence adoption alongside clinical efficacy. Replimune’s win also underscores how accelerated pathways continue to be used for oncology programs where endpoints can support earlier access, while post-approval requirements define the longer-term evidence plan.