FDA Grants Priority Review to Atara Bio's Tab-cel® for EBV+ Post-Transplant Lymphoproliferative Disease

Atara Biotherapeutics, Inc. has announced a significant development with the U.S. Food and Drug Administration (FDA) accepting its Biologics License Application (BLA) for tabelecleucel (tab-cel®). This therapy is intended for adult and pediatric patients aged two and older suffering from Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have previously undergone at least one therapy. This acceptance marks a vital step toward offering a new treatment option in the U.S. for this particular condition, which currently lacks FDA-approved therapies.

The FDA has granted Priority Review to the BLA, with a Prescription Drug User Fee Act (PDUFA) target action date set for January 15, 2025. This accelerated review process underscores the need for effective treatments for EBV+ PTLD, a condition with few existing treatment options and poor survival rates. If approved, tab-cel would become the first therapy of its kind available in the U.S.

Atara Biotherapeutics' President and CEO, Pascal Touchon, highlighted the importance of this milestone, noting the pressing need for new treatments for EBV+ PTLD. The ongoing collaboration with Pierre Fabre Laboratories is aimed at preparing for a potential U.S. launch in early 2025, alongside a planned label expansion multicohort Phase 2 EBVision trial.

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to identify and destroy EBV-infected cells. The BLA is supported by data from over 430 patients treated with tab-cel, including outcomes from the pivotal ALLELE study, which demonstrated a 48.8% Objective Response Rate (ORR) and a favorable safety profile. This therapy has also been granted Breakthrough Therapy Designation for rituximab-refractory EBV-associated lymphoproliferative disease and has orphan drug designation.

In December 2023, Atara announced the expansion of its global partnership with Pierre Fabre Laboratories. This partnership, which initially covered Europe, the Middle East, Africa, and select emerging markets, now includes the U.S. and other global commercial markets. With the acceptance of the BLA, Atara will receive a $20 million milestone payment from Pierre Fabre, and potentially an additional $60 million contingent upon FDA approval. Pierre Fabre will also reimburse Atara for expected global development costs and purchase tab-cel inventory during the manufacturing transfer period. Additionally, Atara stands to earn sales milestones and double-digit tiered royalties from net sales in the U.S. and other global markets.

Tab-cel, marketed under the brand name Ebvallo™, received marketing authorization from the European Commission in December 2022. The Medicines and Healthcare Products Regulatory Agency in the United Kingdom and Swissmedic in Switzerland also granted marketing authorization in May 2023 and May 2024, respectively. In these regions, Ebvallo is indicated as a monotherapy for patients aged two and older with relapsed or refractory EBV+ PTLD who have undergone prior therapy.

Atara Biotherapeutics continues to leverage the natural power of the immune system to develop off-the-shelf cell therapies for challenging cancers and autoimmune conditions. The company boasts a cutting-edge T-cell platform that does not require gene editing and supports a diverse portfolio of investigational therapies targeting EBV. Atara remains committed to pioneering new treatments, with its headquarters located in Southern California.