Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the Ebvallo (tabelecleucel) biologics license application as monotherapy treatment for adult and paediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease, who have received at least one prior therapy including an anti-CD20 containing regimen.
The complete response leter indicates that the FDA is unable to approve the Ebvallo biologics license application in its present form.
