Tabelecleucel (Ebvallo) — 3rd attempt PDUFA Date (Pierre Fabre Pharmaceuticals)
FDA PDUFA decision date for Tabelecleucel (Ebvallo) — 3rd attempt is October 10, 2026. Developed by Pierre Fabre Pharmaceuticals. Indication: EBV+ Post-Transplant Lymphoproliferative Disease. Current status: Upcoming.
Indication
EBV+ Post-Transplant Lymphoproliferative Disease
Notes
Third BLA submission attempt after Jan 2025 and Jan 2026 CRLs.
Regulatory details
- Company: Pierre Fabre Pharmaceuticals
- Therapeutic area: Oncology / Rare Disease
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-10-10
- Outcome: Pending