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

Atara Biotherapeutics, Inc., a leader in T-cell immunotherapy, has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel®). This therapy is designed for adult and pediatric patients, two years of age and older, with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have undergone at least one prior therapy. For solid organ transplant patients, the prior therapy typically includes chemotherapy, unless deemed inappropriate. Currently, there are no FDA-approved treatments for this condition.

The BLA submission marks a pivotal milestone for Atara and its partner, Pierre Fabre Laboratories, as well as the broader field of allogeneic T-cell therapy. Pascal Touchon, President and CEO of Atara, expressed gratitude to the patients and physicians involved in the tab-cel clinical trials, as well as the internal teams and collaborators at Memorial Sloan Kettering Cancer Center. Touchon emphasized the importance of continued collaboration with the FDA and Pierre Fabre in preparation for the potential launch of this first-of-its-kind therapy for EBV+ PTLD patients in the U.S.

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy aimed at targeting and eliminating EBV-infected cells. The BLA is supported by data from over 430 patients treated with tab-cel across various life-threatening diseases, including the pivotal ALLELE study, which demonstrated a statistically significant 48.8% Objective Response Rate (ORR) and favorable safety profile.

The U.S. FDA has granted tab-cel Breakthrough Therapy Designation for treating rituximab-refractory EBV-associated lymphoproliferative disease. It also holds orphan drug designation. Atara's global partnership with Pierre Fabre Laboratories covers the U.S. and other international markets, building on an initial partnership that included Europe, the Middle East, Africa, and select emerging markets. This expanded partnership could potentially bring milestone payments of $20 million and an additional $60 million upon FDA approval of the tab-cel BLA. Additionally, Pierre Fabre is reimbursing Atara for expected global development costs and purchasing tab-cel inventory through the manufacturing transfer date. Atara stands to receive double-digit tiered royalties on net sales of tab-cel 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. It was also approved by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In these regions, Ebvallo is indicated as monotherapy for adult and pediatric patients, two years and older, with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. Again, for solid organ transplant patients, prior therapy includes chemotherapy unless deemed inappropriate.

Atara Biotherapeutics, headquartered in Southern California, aims to harness the immune system's natural power to develop off-the-shelf cell therapies for challenging cancers and autoimmune conditions. Their advanced T-cell platform, which does not require T-cell receptor or HLA gene editing, underpins a diverse portfolio of investigational therapies targeting EBV. Atara is the first company globally to receive regulatory approval for an allogeneic T-cell immunotherapy, marking significant progress in the field.