FDA lifts clinical hold on Atara’s lead treatment
Thousand Oaks-based Atara Biotherapeutics received a bit of good news on May 5, after the U.S. Food and Drug Administration announced that it has lifted its hold on Atara’s active Investigational New Drug application for the Ebvallo program.
Ebvallo, which is already approved in Europe and is used for transplant-related blood cancer, was placed on a clinical hold by the FDA in January. The hold affected the company as Atara announced a 50% reduction in workforce just a week after the FDA’s first rejection letter.
The clinical hold was directly linked to GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter and not anything to do with the actual treatment. The FDA has lifted the clinical hold on Ebvallo after reviewing supplemental data on the finished drug product.
“We are very pleased to have addressed the FDA’s questions, and this has enabled the FDA to lift the clinical holds,” said Atara CEO Cokey Nguyen.
“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 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 Ebvallo’s 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 Nguyen.
Atara shares closed at $7.25 on May 5, down 7.2% despite the positive news.
