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Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Pierre Fabre Pharmaceuticals Inc. (PFP) announces the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc. (Nasdaq: ATRA) with PFP now accountable for all aspects of the submission. Atara will continue to observe the regulatory process and provide support to PFP as needed. The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026. If approved, the tabelecleucel will be indicated as monotherapy for treatment of adult and pediatr
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"Tabelecleucel BLA currently under U.S. Food and Drug Administration (FDA) Priority Review as potentially the first approved therapy in the U.S. for EBV+ PTLD with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026","length":243,"tagName":"p","attribs":{}},{"type":"text","content":"First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment","length":195,"tagName":"p","attribs":{}},{"type":"text","content":"EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression","length":214,"tagName":"p","attribs":{}},{"type":"text","content":"Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide","length":177,"tagName":"p","attribs":{}},{"type":"text","content":"SECAUCUS, N.J., Nov. 3, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the transfer of the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics Inc. (Nasdaq: ATRA) with PFP now accountable for all aspects of the submission. Atara will continue to observe the regulatory process and provide support to PFP as needed. The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026. If approved, the tabelecleucel will be indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy.","length":644,"tagName":"p"},{"type":"image","alt":"The mission of Pierre Fabre Pharmaceuticals (PFP) is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better. PFP is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, a foundation-owned company with seven decades of impact. (PRNewsfoto/Pierre Fabre Pharmaceuticals)","displaySize":"","headline":null,"caption":"The mission of Pierre Fabre Pharmaceuticals (PFP) is to deliver breakth...