一次情報の記録
決定級諮問委員会の日程決定
Replimune: 抗PD-1療法不応の黒色腫におけるRP1+ニボルマブ併用について、FDA諮問委員会(AdComm)開催予定
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.
主要事実
- 提出
- 2026年7月30日 12:06
- イベント
- 諮問委員会の日程決定
- 方向
- 中立
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- カレンダー
- 諮問委員会 · 2026年7月30日 · 承認
- DOR
- 24.8ヶ月 (95% CI: 14.1, NE)
- ORR
- 33.6% (95% CI: 25.8, 42)
出典の抜粋
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