← Back to feed FDA accepts Replimune's RP1 BLA resubmission as Class 1 with Aug 2 PDUFA Sponsor Replimune Group
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Drug RP1 · vusolimogene oderparepvec
Indication Advanced melanoma in patients who have progressed on prior anti-PD-1 therapy (in combination with nivolumab) More on Replimune Group ↗ Google News FDA accepted Replimune's resubmission of the RP1 (vusolimogene oderparepvec) Biologics License Application for advanced melanoma as a Class 1 complete response with a PDUFA target action date of August 2, 2026. FDA notified Replimune to expect an advisory committee meeting in late July. This reverses course after the initial April 2026 review cycle that culminated in a CRL.
Read original at ir.replimune.com ↗ Background Drug-class context · Wikipedia RP1 (vusolimogene oderparepvec) is Replimune's lead oncolytic immunotherapy — an engineered herpes simplex virus type 1 (HSV-1) expressing GM-CSF and a fusogenic glycoprotein. RP1 is administered intratumorally and combines direct oncolytic tumour destruction with systemic antitumour immunity via the encoded immunostimulatory payloads. Replimune first submitted the RP1 + nivolumab combination BLA for anti-PD-1-failed advanced melanoma in 2024; the FDA issued a Complete Response Letter in July 2025. A resubmission was accepted in October 2025 with a PDUFA target of April 10, 2026, but that cycle also concluded with a CRL. Following collaborative FDA communications in May 2026, Replimune resubmitted again — announced May 29, 2026 — and the FDA accepted the current resubmission on June 26, 2026 as a Class 1 (minor amendment) with a compressed 2-month review clock producing an August 2, 2026 PDUFA target. FDA notified Replimune to expect a Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) meeting in late July, prior to the PDUFA decision.
Source: Wikipedia · CC BY-SA
Topic melanoma
