一次情報の記録
決定級FDA 承認
レプリミューン:進行黒色腫でTUDRIQEV+ニボルマブがFDA迅速承認を取得
FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) plus nivolumab in unresectable advanced cutaneous melanoma after anti-PD-1 progression. Approval is based on 24.2% ORR and 14.1-month median DOR from the IGNYTE trial; continued approval requires confirmatory Phase 3 IGNYTE-3 data.
主要事実
- 提出
- 2026年8月7日 01:27
- イベント
- FDA 承認
- 方向
- ポジティブ
- 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
出典の抜粋
EX-99.1 2 tm2622487d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces FDA Accelerated Approval of TUDRIQEV TM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., August 6, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEV TM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of