TUDRIQEV (vusolimogene oderparepvec; RP1) + nivolumab
Advanced melanoma after prior anti-PD-1 therapy · Adults with advanced melanoma who previously received an anti-PD-1-containing regimen
REPL · Replimune Group
監管認定
完整時間線
8 個里程碑FDA granted accelerated approval to TUDRIQEV plus nivolumab
FDA granted accelerated approval for TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed after anti-PD-1-based therapy. The decision followed the July 30 advisory committee recommendation and was announced four days after the original August 2 goal date.
Replimune — FDA accelerated approval of TUDRIQEV plus nivolumab↗CTGTAC voted 10–3 for clinically meaningful benefit
The FDA advisory committee voted 10–3 that RP1 plus nivolumab provides clinically meaningful benefit for adults with advanced melanoma previously treated with an anti-PD-1-containing regimen. The recommendation is non-binding and the FDA decision remained pending.
FDA — July 30 CTGTAC meeting materials and webcast↗Three-year IGNYTE survival analysis reported
Replimune reported that 47.8% of treated patients were alive at three years and median overall survival was 32.9 months in the anti-PD-1-failed melanoma population.
Replimune — Three-year IGNYTE overall survival update↗FDA accepted the latest BLA resubmission
FDA accepted the resubmission as a complete Class 1 response and assigned an August 2, 2026 goal date.
Replimune — FDA acceptance of the RP1 BLA resubmission↗相關新聞
Replimune Reports Fiscal First Quarter 2027 Financial Results and Provides Corporate Update
2026年8月10日Replimune Announces Pricing of $150 Million Underwritten Offering
2026年8月6日Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen
2026年7月30日Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma
2026年6月29日Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update