The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025. The FDA has accepted the biologics license application (BLA) for ...
The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is ...
The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3 ...
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the FDA with priority review. The FDA accepted the biologics license ...
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