EU Approves Atara’s Ebvallo for Posttransplant Lymphoproliferative Disease

The European Commission has approved Atara Biotherapeutics’ Ebvallo (tabelecleucel) as a monotherapy for adults and children two years and older who have relapsed or refractory Epstein-Barr virus positive post‑transplant lymphoproliferative disease and who received at least one prior therapy.

The EU approval follows the October positive opinion from the Committee for Medicinal Products for Human Use, based on results from a phase 3 study in which Ebvallo showed an overall response rate of 50 percent.

Under a licensing agreement, Atara will transfer the EU marketing authorization to Pierre Fabre, a company that will lead commercialization and distribution activities in Europe.