Atara Biotherapeutics, Inc., a leading player in T-cell immunotherapy, has achieved a significant milestone by submitting a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel (tab-cel®). This therapy is intended for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in both adult and pediatric patients aged two and above, who have previously undergone at least one treatment. It's noteworthy that there are currently no FDA-approved therapies available for this condition.

Atara, expressed gratitude to the patients, physicians, and collaborators who participated in the clinical trials. The BLA submission marks a pivotal moment not only for Atara but also for its partner, Pierre Fabre, and the wider field of allogeneic T-cell therapy.

Tab-cel, an allogeneic, EBV-specific T-cell immunotherapy, is designed to target and eliminate EBV-infected cells. Its BLA is supported by comprehensive data from studies involving over 430 patients, including the recent pivotal ALLELE study, which demonstrated a significant Objective Response Rate (ORR) of 48.8% and a favorable safety profile.

With Breakthrough Therapy Designation and orphan drug designation from the FDA, tab-cel holds promise as a breakthrough therapy for rituximab-refractory EBV-associated lymphoproliferative disease. Atara's expanded partnership with Pierre Fabre positions them well for potential FDA approval, with milestone payments and reimbursement for development costs. Additionally, Atara stands to receive royalties on tab-cel sales in the U.S. and other global markets.

Having already received marketing authorization in Europe and other territories, tab-cel's journey toward approval in the U.S. underscores its potential to address unmet medical needs for patients with EBV+ PTLD.

 

Source: businesswire.com

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