Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

Atara Biotherapeutics submits a Biologics License Application to the FDA for tabelecleucel (tab-cel®) as monotherapy for EBV+ PTLD patients who have received at least one prior therapy, with no FDA approved therapies in this setting. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, supported by pivotal data from over 430 patients. The therapy has Breakthrough Therapy and orphan drug designations, and has received marketing authorization in Europe, UK, and Switzerland under the brand name Ebvallo™.