Pierre Fabre Pharmaceuticals, Inc. (PFP), announces it has aligned with FDA on a potential path forward for resubmission of the BLA for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for patients with Relapsed/Refractory (R/R) Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) who have received at least one prior therapy including an anti-CD20 containing regimen.

"We thank the FDA review team for a productive discussion on the tabelecleucel BLA and look forward to finalizing the resubmission plan with the agency in the coming weeks," said Adriana Herrera, Chief Executive Officer of PFP, the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "U.S. patients living with this ultra-rare form of lymphoma urgently need an FDA-approved treatment option as none currently exist, and the lifespan of individuals with R/R EBV+ PTLD is often measured in weeks to months following failure of standard treatment."

During the meeting, the FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a marketing application of tabelecleucel for the proposed indication. As a part of the resubmission plan being defined with the FDA, PFP will submit an updated dataset with additional patients and longer follow up from the pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data.