Atara partner resubmits tabelecleucel FDA application
- Atara Biotherapeutics (NASDAQ:ATRA) announced that partner Pierre Fabre Pharmaceuticals resubmitted the tabelecleucel Biologics License Application to the FDA.
- The resubmission includes updated Phase 3 ALLELE study data with additional patients and longer follow-up.
- Atara is eligible for a $31 million milestone payment if the FDA approves the tabelecleucel application.
Atara Biotherapeutics (NASDAQ:ATRA) announced that partner Pierre Fabre Pharmaceuticals resubmitted the Biologics License Application (BLA) for tabelecleucel to the U.S. Food and Drug Administration for treatment of relapsed or refractory EBV-positive post-transplant lymphoproliferative disease.
The resubmission follows feedback from an FDA Type A meeting held in April and includes additional patient data and longer follow-up from the pivotal Phase 3 single-arm ALLELE study.
The updated application includes supplemental data from expanded access programs, a separate clinical study and commercial experience in Europe, while Atara stated that partner Pierre Fabre Pharmaceuticals will continue preparing for the FDA review process.
Tabelecleucel is an allogeneic Epstein-Barr virus (EBV) T-cell therapy being developed for patients with EBV-positive post-transplant lymphoproliferative disease following solid organ transplant or hematopoietic cell transplant.
Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval, along with tiered double-digit royalties based on net sales and additional commercial sales milestones.
