First Allogeneic T-Cell Therapy BLA Filing acceptance by U.S.
Food and Drug Administration with a Prescription Drug User Fee Act
(PDUFA) Target Action Date of January 15,
2025
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.
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)
PARSIPPANY, N.J., July 18,
2024 /PRNewswire/ -- Pierre Fabre
Pharmaceuticals Inc. announces the acceptance by U.S Food and Drug
Administration (FDA) of the Biologics License Application (BLA) and
Priority Review of Tabelecleucel (Tab-cel®), 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.
The BLA has been granted Priority Review with a Prescription
Drug User Fee Act (PDUFA) target action date of January 15, 2025.
"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. Today's 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." said Adriana
Herrera, Chief Executive Officer of Pierre Fabre
Pharmaceuticals Inc., the new Pierre Fabre Medical Care subsidiary
in the United States.
"Following international recognition on June 24 for Tab-cel® with the Galien
International Prize, we know we are on the right path to embody our
purpose: every time we take care for a single person, we make the
whole world better."
CONTACT: Geoffrey Cook,
geoff@cookgm.co
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SOURCE Pierre Fabre Pharmaceuticals Inc.