Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
The FDA accepted Atara Biotherapeutics' BLA for tabelecleucel (tab-cel®) for EBV+ PTLD, granting Priority Review with a PDUFA date of January 15, 2025. Tab-cel is an allogeneic EBV-specific T-cell immunotherapy with Breakthrough Therapy and orphan drug designations, aiming to treat patients with at least one prior therapy. The BLA is supported by pivotal data from over 430 patients, showing a 48.8% Objective Response Rate. Atara has a global partnership with Pierre Fabre Laboratories for tab-cel commercialization, with potential milestone payments upon FDA approval.
Highlighted Terms
Related News
The FDA accepted Atara Biotherapeutics' BLA for tabelecleucel (tab-cel®) for EBV+ PTLD, granting Priority Review with a PDUFA date of January 15, 2025. Tab-cel is an allogeneic EBV-specific T-cell immunotherapy with Breakthrough Therapy and orphan drug designations, aiming to treat patients with at least one prior therapy. The BLA is supported by pivotal data from over 430 patients, showing a 48.8% Objective Response Rate. Atara has a global partnership with Pierre Fabre Laboratories for tab-cel commercialization, with potential milestone payments upon FDA approval.