预约演示

Pierre Fabre Laboratories announces the submission by Atara Biotherapeutics of Tabelecleucel (Tab-cel®) Biologics License Application for treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S FDA

2024-05-20

免疫疗法临床3期细胞疗法上市批准

First Allogeneic T-Cell Therapy BLA Submission to U.S. Food and Drug Administration

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.

CASTRES, France, May 20, 2024 /PRNewswire/ -- Pierre Fabre Laboratories today announce the submission by Atara Biotherapeutics (ATARA), a leader in T-cell immunotherapies, of Tabelecleucel (Tab-cel®) Biologics License Application for treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S Food and Drug Administration (FDA), indicated as monotherapy for treatment of 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. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

View PDF

"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.