Pierre Fabre Pharmaceuticals 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.

Adriana Herrera, Chief Executive Officer, PFP, the Pierre Fabre Laboratories pharmaceutical subsidiary in the US, said, "We thank the FDA review team for a productive discussion on the tabelecleucel BLA and look forward to finalising the resubmission plan with the agency in the coming weeks. US 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 2 years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data.