Pierre Fabre outlines FDA path forward for tabelecleucel after setback

Privately-held French drugmaker Pierre Fabre Pharmaceuticals says it has reached agreement with the US Food and Drug Administration (FDA) on a potential path forward for resubmitting the Biologics License Application (BLA) for tabelecleucel, following a recent Type A meeting with the agency.
The allogeneic T-cell therapy is being developed for relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), a rare and life-threatening lymphoma that can develop in patients following organ or stem cell transplantation.

Regulatory route clarified