French pharmaceutical and dermo-cosmetic group Pierre Fabre Pharmaceuticals Inc announced on Thursday that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and Priority Review of Tabelecleucel (Tab-cel), indicated as monotherapy for treatment of adult and paediatric patients of 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.

The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of 15 January 2025.

Adriana Herrera, chief executive officer of the new Pierre Fabre Medical Care subsidiary in the United States, said: "Patients facing relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and with current therapeutic options their survival is unfortunately often measured in weeks or months. Today's BLA acceptance is a significant step towards making Tab-cel available to patients in the United States.

"We congratulate our partner ATARA on this significant achievement and are now focused on preparing for potential FDA approval and launch of this innovative new treatment option for EBV+ PTLD."