Priority Review for Atara Gene Therapy

FDA has accepted for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel (tab-cel) indicated as monotherapy for treating adult and pediatric patients two years of age and older with Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease who have received at least one prior therapy. The agency has set a user fee review action target date of 1/15/2025.

Tab-cel is described as an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The submission is based on pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, the company says. Data from the latest pivotal allele study demonstrated a statistically significant 48.8% objective Response Rate and a favorable safety profile consistent with previous analyses, it adds.