Ebvallo FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 17, 2025.
FDA Approved: No
Brand name: Ebvallo
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.
- On January 16, 2025, Atara Biotherapeutics, Inc. announced that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Ebvallo (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen. The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for Ebvallo. The CRL did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support the approval of Ebvallo.
Development timeline for Ebvallo
Further information
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