Atara Biotherapeutics Submits FDA Application for Tabelecleucel to Treat Post-Transplant Lymphoproliferative Disease

Pierre Fabre Laboratories has announced that Atara Biotherapeutics (ATARA), a leader in T-cell immunotherapies, has submitted a Biologics License Application (BLA) for Tabelecleucel (Tab-cel®) to the U.S. Food and Drug Administration (FDA). This submission aims to treat Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) as a monotherapy for adults and children aged two years and older who have received at least one prior therapy. For patients who have undergone a solid organ transplant, this prior therapy typically includes chemotherapy unless it is deemed inappropriate. Currently, there are no FDA-approved therapies for this condition.

The BLA submission is backed by data from the pivotal Phase 3 ALLELE study. This study focused on evaluating the efficacy of Tab-cel in patients with relapsed or refractory EBV+ PTLD following either a solid organ transplant (SOT) or a hematopoietic cell transplant (HCT). If the FDA grants approval, Tab-cel would become the first approved treatment in the U.S. for EBV+ PTLD. The newly formed subsidiary, Pierre Fabre Pharmaceuticals Inc., will be responsible for its commercialization in the United States.

"Patients dealing with relapsed or refractory EBV+ PTLD have extremely limited therapeutic options, and their survival is often measured in weeks or months," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc. "The filing of the BLA is a major milestone towards making Tab-cel® accessible to patients in the United States. We commend our partner ATARA for this significant achievement and are now gearing up for the potential FDA review and approval."

The importance of this development cannot be overstated. EBV+ PTLD is a serious complication that arises after organ or stem cell transplants, leading to significant morbidity and mortality. The disease is highly aggressive and, without effective treatment options, the prognosis for these patients is often grim. The submission of the BLA for Tab-cel represents a beacon of hope for those affected by this condition.

In summary, the recent submission of the Biologics License Application for Tab-cel® to the FDA marks a crucial step in providing a viable treatment option for individuals suffering from EBV+ PTLD. The data supporting this application comes from a comprehensive Phase 3 study, underscoring the potential of Tab-cel to address a significant unmet medical need. Should the FDA approve the application, it would pave the way for the first approved therapy for EBV+ PTLD in the United States, offering new hope to both adult and pediatric patients grappling with this life-threatening disease.