Priority Review Granted by FDA for RP1 Plus Nivolumab in Advanced Melanoma

By: JNCCN 360 Staff
Posted: Monday, January 27, 2025

The U.S. Food and Drug Administration (FDA) recently accepted the biologics license application of vusolimogene oderparepvec (also known as RP1) in combination with the PD-1 inhibitor nivolumab for patients with advanced melanoma and designated the application for Priority Review, according to an announcement from Replimune Group, Inc. RP1 is a genetically modified oncolytic viral strain of the herpes simplex type 1 virus.

The biologics license application is supported by the primary analysis data of the IGNYTE trial, which is evaluating RP1 combined with nivolumab in patients with melanoma who experienced disease progression on a PD-1 inhibitor. A confirmatory phase III trial, IGNYTE-3 (ClinicalTrials.gov identifier NCT06264180), is currently underway, with more than 100 sites planned globally. IGNYTE-3 is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have experienced disease progression on anti–PD-1 and anti–CTLA-4 therapies or are ineligible for anti–CTLA-4 treatment.

BioSpace

---