- Atara Biotherapeutics (ATRA, Financial) has resubmitted a Biologics License Application (BLA) for tabelecleucel (tab-cel®) to the U.S. FDA.
- FDA approval could trigger a $40 million milestone payment from Pierre Fabre Laboratories.
- The pivotal ALLELE study showed a significant 48.8% Objective Response Rate.
Atara Biotherapeutics, Inc. (ATRA), a leader in T-cell immunotherapy, announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO™ or tab-cel®). Intended as a monotherapy, tabelecleucel is aimed at treating adult and pediatric patients aged two years and older suffering from Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have undergone at least one prior therapy. If approved, this would mark the first FDA-approved therapy in this treatment setting.
The resubmission comes after addressing third-party manufacturing facility observations with major input from its partner, Pierre Fabre Laboratories. Atara is looking forward to continued dialogue with the FDA during the review process. Notably, FDA approval of the BLA could lead to a $40 million milestone payment from Pierre Fabre Laboratories.
Tabelecleucel is designed as an allogeneic, EBV-specific T-cell immunotherapy to target EBV-infected cells. Over 430 patients have been treated with tab-cel, with pivotal ALLELE study data showing a significant 48.8% Objective Response Rate (p
In corporate developments, Atara is concluding the transfer of clinical studies related to tab-cel to Pierre Fabre Laboratories. Operational activities and costs for tab-cel will also transition to Pierre Fabre Laboratories, while Atara retains sponsorship of the BLA.
Financially, Atara projects that its cash, cash equivalents, and short-term investments of approximately $22 million as of June 30, 2025, will fund operations into the first quarter of 2026. The company is positioned to receive significant royalties and sales milestones from Pierre Fabre Laboratories upon successful commercialization of tabelecleucel.
