The FDA approved Replimune’s intratumoral oncolytic virus therapy for advanced melanoma after a sequence of prior rejections, granting accelerated approval for Tudriqev (formerly RP1). The decision allows use alongside Bristol Myers Squibb’s Opdivo in patients whose melanoma progressed on PD-1–blocking immunotherapies. The approval was supported by a single-arm trial in which roughly one-quarter of patients had a tumor response, with effects lasting a median of just over 14 months. FDA advisers previously supported the approach despite concerns from FDA staff about trial design and response assessment. Replimune’s confirmatory Phase 3 trial is intended to provide more definitive readouts in late 2027, continuing accelerated-approval obligations for durability of benefit.