Tabelecleucel FDA Approval Status
Last updated by Judith Stewart, BPharm on July 21, 2024.
FDA Approved: No
Generic name: tabelecleucel
Company: Atara Biotherapeutics, Inc.
Treatment for: EBV-Positive Post-Transplant Lymphoproliferative Disease
Tabelecleucel (tab-cel) is an allogeneic, EBV-specific T-cell immunotherapy in development for the treatment of patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
- EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) is a hematologic malignancy that occurs after transplantation when a patient's T-cell activity is compromised by immunosuppression. It can impact patients who have undergone solid-organ transplant (SOT) or an allogeneic hematopoietic cell transplantation (HCT).
- Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy that works in the treatment of EBV+ PTLD by targeting and eliminating EBV-infected cells.
- Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.
- The BLA for tab-cel has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.
Development timeline for tabelecleucel
Further information
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