Replimune’s RP1 (vusolimogene oderparepvec) moved back toward the clinical spotlight after an FDA advisory committee vote. The update centers on the panel’s support for RP1 in combination with nivolumab for patients with anti–PD-1-refractory advanced melanoma, even after negative briefing documents. The decision underscores how the regulatory pathway for oncology gene therapies can swing based on the balance of single-arm registrational data and safety considerations. Replimune submitted its biologics license application (BLA) for RP1 plus nivolumab in November 2024, with breakthrough therapy designation and priority review tied to an IGNYTE phase 1/2 registrational cohort. For investors and trial designers, the key near-term effect is uncertainty reduction: it suggests the agency may be more receptive to RP1 in the next-stage review cycle, while still leaving details to be worked through in post-panel interactions.