FDA Accepts Tabelecleucel BLA Resubmission for EBV+ PTLD – Atara Biotherapeutics
Atara Biotherapeutics, Inc. announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the FDA of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
The BLA has a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.
“The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S. We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential U.S. launch.” – Cokey Nguyen, President and Chief Executive Officer of Atara.
Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.
If tabelecleucel is approved, Atara would be eligible to receive a $31 million milestone payment under its commercialization agreement with Pierre Fabre Laboratories. Atara would also be eligible to receive significant double-digit tiered royalties on net sales and additional commercial sales milestones.
