Pierre Fabre Pharmaceuticals announced the FDA has agreed to Type A meeting for the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory (R/R) Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD).
"We look forward to a collaborative and productive discussion with the FDA on a timely path forward to achieving accelerated approval of tabelecleucel in R/R EBV+ PTLD, an acute disease with no FDA-approved treatment options," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "It is essential to agree upon a timely approach to resubmission as the lifespan of patients with R/R EBV+ PTLD in the U.S. is often measured in weeks to months following failure of standard treatment."
The meeting will address the Complete Response Letter received by PFP from the agency on January 9, 2026. The company anticipates providing a regulatory update on the outcome of the meeting in the second quarter.
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