Atara Biotherapeutics to submit Tab-cel BLA after FDA compatibility agreement

Atara Biotherapeutics reported important progress related to the regulatory pathway for tabelecleucel, or tab-cel, in the U.S. Following productive discussions between Atara and the FDA, the FDA and Atara are now aligned on analytical comparability between manufacturing process versions. This alignment supports Atara’s ability to pool the pivotal clinical trial data from different process versions in the Biologics License Application submission. Atara expects to submit the tab-cel BLA in Q2 2024, which will enable Atara to incorporate the latest tab-cel pivotal trial data from the ALLELE study into the BLA filing package. Tabelecleucel is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner. Epstein-Barr virus-positive post-transplant lymphoproliferative disease is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant or allogeneic hematopoietic cell transplant. Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.