By IDSE News Staff
The FDA issued a complete response letter (CRL) to Atara Biotherapeutics for tabelecleucel (Ebvallo) as monotherapy treatment for adults and children 24 months of age and older with Epstein-Barr virus–positive post-transplant lymphoproliferative disease (EBV+PTLD), who have received at least one prior therapy including an anti-CD20–containing regimen.
The CRL was related to observations as part of a standard prelicense inspection of a third-party manufacturing