FDA lifts hold on Ebvallo

Atara Biotherapeutics, Inc., a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases,  announced that the FDA has lifted the clinical hold on Atara’s active Investigational New Drug (IND) applications for the Ebvallo (tabelecleucel) 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  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. “We are pleased that the FDA has granted our request for a Type A meeting and hope to gain clarity on the timing for resubmitting the tab-cel BLA for review by the FDA,” said Dr. Nguyen.