The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for Pierre Fabre Pharmaceuticals’ Tabelecleucel (Tab-cel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Tabelecleucel is being developed as a monotherapy for EBV+ PTLD treatment in adult and paediatric patients aged two years and above who have undergone a minimum of one previous therapy.

It is an allogeneic, EBV-specific T-cell immunotherapy and acts on EBV-infected cells.

The company’s BLA is supported by the outcomes of 430 subjects who received Tab-cel.

For patients who have received solid organ transplants, previous therapy typically includes chemotherapy, except in cases where this is deemed inappropriate.

No FDA-approved therapies are currently available for this treatment setting.

A decision by the US regulator under the Prescription Drug User Fee Act (PDUFA) is anticipated by 15 January 2025.

In November 2023, Pierre Fabre Laboratories obtained marketing rights to Ebvallo (tabelecleucel) from Atara Biotherapeutics in North America, Asia Pacific, and Latin America in a $640mdeal.

Pierre Fabre Pharmaceuticals CEO Adriana Herrera stated: “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.

“The 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.”

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