Overview
- The FDA granted accelerated approval on August 6–7, 2026, for vusolimogene oderparepvec (RP1, Tudriqev) plus nivolumab to treat adults with unresectable advanced cutaneous melanoma that progressed on prior PD‑1 therapy.
- The approval rested on the phase 1/2 IGNYTE registrational cohort, in which 91 efficacy‑evaluable patients had an objective response rate of 24.2% and a median duration of response of 14.1 months as measured by blinded independent central review.
- The decision follows a fraught review history that included two earlier FDA complete response letters and a July 30, 2026, CBER advisory committee vote of 10–3 finding the IGNYTE data evaluable and clinically meaningful.
- Labeling and safety guidance note serious adverse reactions in about 35% of trial patients plus risks tied to the herpes simplex viral vector, accidental exposure, injection‑site complications, and detailed intratumoral dosing instructions for clinicians.
- Replimune set a list price near $450,000 per course, a figure likely to shape payer coverage and patient access while regulators, clinicians, and the ongoing IGNYTE‑3 phase 3 trial determine whether the single‑arm findings translate into verified clinical benefit.