Posted by Michael Wonder on 17 Jan 2025
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
16 January 2025 - Atara received FDA complete response letter solely related to inspection findings at third party manufacturer.
Atara Biotherapeutics today announced it received a complete response letter from the US FDA for the Ebvallo (tabelecleucel) biologics license application as monotherapy treatment for adult and pediatric 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.
