Pierre Fabre Pharmaceuticals submitted a request to the FDA for a Type A meeting on the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD), to address the January 9, 2026 Complete Response Letter from the agency.
"We look forward to meeting with the agency to discuss a path forward that achieves accelerated approval of tabelecleucel in R/R EBV+ PTLD. People living with this ultra-rare form of lymphoma urgently need an FDA-approved treatment option as none currently exist," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "We approach this meeting with a sense of urgency and strong support from the patient and medical communities as the lifespan of individuals with R/R EBV+ PTLD is often measured in weeks to months following failure of standard treatment."
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