- 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.
"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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