Record mula sa primary source
Decision-gradeNaiskedyul ang advisory committee
Replimune: FDA AdComm nakatakda para sa RP1 + nivolumab sa anti-PD-1 failed melanoma
Ang FDA ay nakatakda ng pulong ng Cellular, Tissue and Gene Therapies Advisory Committee sa Hulyo 30, 2026 upang suriin ang BLA para sa vusolimogene oderparepvec-wtpg (RP1) kasama ang nivolumab. Ang aplikasyon ay naghahanap ng accelerated approval batay sa single-arm IGNYTE Phase 2 trial na nagpakita ng 33.6% ORR at 24.8-buwan na median DoR sa anti-PD-1 progressed cutaneous melanoma.
Mahahalagang fact
- Na-file
- Hul 30, 2026, 12:06 PM
- Kaganapan
- Naiskedyul ang advisory committee
- Direksyon
- Neutral
- Kumpanya
REPLReplimune- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Advisory committee · Hul 30, 2026 · Inaprubahan
- Tagal ng tugon
- 24.8 buwan (95% CI: 14.1, NE)
- Kabuuan ng rate ng tugon
- 33.6% (95% CI: 25.8, 42)
Sipi mula sa source
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
Higit pa tungkol sa asset na ito
Decision-grade
Ago 7, 2026
01:27 AM
REPLReplimune