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Replimune: FDA lên lịch họp AdComm cho RP1 kết hợp nivolumab trong u hắc tố kháng trị anti-PD-1
The FDA has scheduled a Cellular, Tissue and Gene Therapies Advisory Committee meeting for July 30, 2026 to review the BLA for vusolimogene oderparepvec-wtpg (RP1) in combination with nivolumab. The application seeks accelerated approval based on the single-arm IGNYTE Phase 2 trial showing 33.6% ORR and 24.8-month median DoR in anti-PD-1 progressed cutaneous melanoma.
Thông tin chính
- Nộp lúc
- 12:06 30 thg 7, 2026
- Sự kiện
- Lên lịch ủy ban cố vấn
- Chiều hướng
- Trung lập
- Công ty
REPLReplimune- Nguồn
- SEC 8-K
- Độ tin cậy
- Có nguồn
- Lịch
- Ủy ban cố vấn · 30 thg 7, 2026 · Được phê duyệt
- DOR
- 24,8 tháng (95% CI: 14,1, NE)
- ORR
- 33,6% (95% CI: 25,8, 42)
Trích đoạn nguồn
EX-99.1 2 tm2621663d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 CC-1 Vusolimogene oderparepvec-wtpg (TUDRIQEV ) in Combination with Nivolumab for the Treatment of Adults with Unresectable Advanced Cutaneous Melanoma July 30, 2026 United States Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee CC-2 Introduction Kari Jeschke, MA Senior Vice President, Regulatory Affairs, Replimune, Inc. CC-3 Melanoma Community Support for Urgent Access to RP1 CC-4 TUDRIQEV is indicated in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with an anti-programmed death receptor-1 (PD-1) based regimen Proposed Indication Statement CC-5 Favorable Benefit-Risk for Accelerated Approval IGNYTE-3
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