Business

Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

THOUSAND OAKS, Calif., July 24, 2025--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric pa

articleAtara Biotherapeutics, Inc.July 24, 20254/company/atara-biotherapeutics-inc/news/atara-biotherapeutics-announces-u-fda-120000453
Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

About this update from Atara Biotherapeutics, Inc.

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":3000,"height":912,"url":"https://media.zenfs.com/en/business-wire.com/818d73f831eddf35f063f3d5da4e8e3e"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/gr5GYVxYA2HYi1YlGXdQbA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTI5MjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/818d73f831eddf35f063f3d5da4e8e3e","width":960,"height":292},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/n7efkQ2wdaspHw_BrF9QjQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTI0MDA7aD03MzA7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/818d73f831eddf35f063f3d5da4e8e3e","width":1200,"height":365}},"lazy":false},{"type":"text","content":"Prescription Drug User Fee Act (PDUFA) Target Action Date of January 10, 2026","length":77,"tagName":"p","attribs":{}},{"type":"text","content":"If Approved, Tab-cel Would Be First Approved Therapy in U.S. for EBV+ PTLD","length":74,"tagName":"p","attribs":{}},{"type":"text","content":"THOUSAND OAKS, Calif., July 24, 2025--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of 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. There are no FDA approved therapies in this treatment setting.","length":748,"tagName":"p"},{"type":"text","content":"The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.","length":147,"tagName":"p"},{"type":"text","content":""The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We continue to work closely with the Pierre Fabre Pharmaceuticals team to help prepare for the p...

More updates from Atara Biotherapeutics, Inc.

Epstein-Barr virusFood and Drug Administrationautoimmune diseaseslymphoproliferative diseaseAtara Biotherapeutics, Inc.Pierre FabreAtarapediatric patientsinvestigational therapiesBiologics License Application