FDA Accepts Tabelecleucel BLA for Priority Review with PDUFA Date Set for January 2026

Reuters11-03

FDA Accepts Tabelecleucel BLA for Priority Review with PDUFA Date Set for January 2026

Atara Biotherapeutics Inc., in collaboration with Pierre Fabre Pharmaceuticals Inc. (PFP), announced that the Biologics License Application (BLA) for tabelecleucel, a novel allogeneic T-cell therapy, has been transferred to PFP and is currently under Priority Review by the U.S. Food and Drug Administration (FDA). The BLA, accepted by the FDA on July 23, 2025, has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. If approved, tabelecleucel would be indicated as monotherapy 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. Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Atara Biotherapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NY13337) on November 03, 2025, and is solely responsible for the information contained therein.

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