Atara Biotherapeutics: FDA lifts clinical hold on IND applications for Ebvallo

Atara Biotherapeutics (ATRA) announced that the U.S. FDA has lifted the clinical hold on Atara’s active Investigational New Drug applications for the Ebvallo program. “We are very pleased to have addressed the FDA’s questions, and this has enabled the FDA to lift the clinical holds,” said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. “We are working closely with our partner Pierre Fabre Laboratories and our clinical trial sites and anticipate resuming enrollment and treatment of patients as soon as possible.” The FDA has lifted the clinical hold on tabelecleucel after reviewing supplemental data on finished drug product. The company is now allowed to restart the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease and the Phase 2 label-expansion multi-cohort clinical study. The FDA has also granted a date for a Type A meeting to discuss the plan to address the issues raised by the FDA in the CRL from January 2025, and the path forward for resubmission of the Ebvallo BLA.