Atara Biotherapeutics Inc. Resumes Clinical Trials for EBVALLO™ After FDA Lifts Hold

Atara Biotherapeutics Inc. has announced a significant regulatory update regarding its EBVALLO™ (tabelecleucel) program. The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Atara's active Investigational New Drug (IND) applications for this program. This decision allows Atara to resume its Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study. The clinical hold, initially placed in January 2025 due to GMP compliance issues at a third-party manufacturing facility, has been resolved following the FDA's review of supplemental data. Additionally, the FDA has granted a Type A meeting to discuss the path forward for the resubmission of the EBVALLO™ Biologics License Application (BLA). Atara is set to work closely with its partner, Pierre Fabre Laboratories, to resume patient enrollment and treatment promptly.