Pierre Fabre Pharmaceuticals and Atara Biotherapeutics Advance Cell Therapy with FDA Priority Review
SECAUCUS, N.J. – July 24, 2025 – Pierre Fabre Pharmaceuticals Inc. (PFP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review to the Biologics License Application (BLA) for tabelecleucel. This innovative monotherapy is indicated for adult and pediatric patients aged two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
Atara Biotherapeutics Inc. (Nasdaq: ATRA) resubmitted the tabelecleucel BLA on July 11, after swiftly resolving, in collaboration with PFP, third-party manufacturing facility observations outlined in a January 2025 Complete Response Letter.
“Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and their survival is unfortunately measured in only weeks to months,” said Adriana Herrera, Chief Executive Officer of PFP. “Today’s BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the United States.”
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA includes data from over 430 treated patients, including the pivotal ALLELE study. Tabelecleucel has already received marketing authorization in Europe (EBVALLO), the UK, and Switzerland.
Source:
https://www.prnewswire.com/news-releases/pierre-fabre-pharmaceuticals-inc-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-tabelecleucel-for-the-treatment-of-epstein-barr-virus-positive-post-transplant-lymphoproliferative-disea-302513152.html
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