Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported important progress related to the regulatory pathway for tabelecleucel (tab-cel®) in the U.S.
Following productive discussions between Atara and the U.S. Food and Drug Administration (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 (BLA) 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.
https://finance.yahoo.com/news/atara-biotherapeutics-announces-plans-submit-200100061.html
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