Also known as: Ebvallo, EBVALLO, tab-cel
Tabelecleucel is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy marketed as Ebvallo in Europe. It is used for relapsed or refractory EBV-positive post-transplant lymphoproliferative disease after prior therapy in adults and children aged 2 years and older. The medicine is authorized in the European Union under exceptional circumstances.
Class action lawsuits allege securities violations by Atara Biotherapeutics and Inovio Pharmaceuticals related to FDA submissions. Atara faces claims over manufacturing issues with its tabelecleucel BLA, while Inovio is accused of misleading statements about INO-3107 regulatory timelines and manufacturing deficiencies.
Class action lawsuits allege false statements about clinical trial results and regulatory prospects at Atara Biotherapeutics, Ultragenyx, Mereo BioPharma, and Vistagen Therapeutics. The complaints cite failed Phase 3 studies for setrusumab in Osteogenesis Imperfecta and fasedienol for social anxiety disorder, along with manufacturing issues affecting Atara's tabelecleucel application. Investors have deadlines ranging from April to May 2026 to seek lead plaintiff status.
Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.
The FDA issued a Complete Response Letter for Atara Biotherapeutics' Ebvallo application, reversing its prior acceptance of the ALLELE trial design. Partner Pierre Fabre Pharmaceuticals has requested a Type A meeting to address the agency's concerns.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT04554914 |
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT03769467 |
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC) |
TERMINATED | PHASE1/PHASE2 |
| NCT03394365 |
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy |
RECRUITING | PHASE3 |
| NCT02822495 |
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies |
NO_LONGER_AVAILABLE |
