- 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 21, 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.
"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.
Pierre Fabre Laboratories Media Contact:
Laurence Marchal, Laurence.marchal@pierre-fabre.com
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SOURCE Pierre Fabre