FDA Places Clinical Hold on Atara Biotherapeutics’ EBVALLO and ATA3219 Due to Manufacturing Compliance Issues

Clinical Hold:
The U.S. FDA has placed a clinical hold on Atara Biotherapeutics' active Investigational New Drug (IND) applications for EBVALLO (tabelecleucel) and ATA3219 due to manufacturing compliance issues13.

Reason for Hold:
The clinical hold is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of a third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO1.

Affected Programs:
The hold affects the EBVALLO program for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and the ATA3219 program for non-Hodgkin’s lymphoma and systemic lupus erythematosus1.

Continuation of Treatment:
Patients currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocols, but screening and enrollment of new participants have been paused1.

Resolution Efforts:
Atara and the FDA have discussed and agreed upon the actions necessary to release the clinical holds, with the FDA committed to working collaboratively and expeditiously with Atara to resolve the issues1.

Manufacturing Strategy:
The compliance issues are specific to one third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California, which remains a critical component of Atara’s long-term manufacturing strategy1.

Sources:

1. https://investors.atarabio.com/news-events/press-releases/detail/368/atara-biotherapeutics-provides-update-on-clinical-programs

3. https://www.fiercepharma.com/pharma/ataras-ebvallo-and-car-t-candidate-put-under-clinical-hold-us-following-manufacturing