Pierre Fabre Pharmaceuticals has resubmitted its application for tabelecleucel, a cell therapy for a rare and often fatal lymphoma that can strike after an organ or stem cell transplant, Atara Biotherapeutics said Sept. 30. It is the third time the therapy has gone before the FDA.
The resubmission follows two rejections. The second, in January 2026, came after the FDA said the single-arm trial behind the application was no longer considered adequate to show the drug works. Months later, after a meeting with the companies, the agency agreed that a single-arm study with an appropriate historical comparison could serve as adequate evidence.
