The BLA is supported by data from the pivotal Phase 3 ALLELE study which was investigating Tab-cel in relapsed or refractory EBV+ PTLD following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) If Approved, Tab-cel Would be the First Approved Therapy in U.S. for EBV+ PTLD and will be commercialized in the US by the newly established subsidiary Pierre Fabre Pharmaceuticals Inc. "Patients facing relapsed or refractory EBV+ PTLD have limited therapeutic options and their survival is unfortunately often measured in weeks or months. Filing of the BLA 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 the potential FDA review and approval" said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the new Pierre Fabre Medical Care subsidiary in the United States. For more information, visit www.pierre-fabre.com, @PierreFabreGroup.
Laboratories Media Contact:
Laurence Marchal, [email protected]
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