The European Commission (EC) has granted marketing authorization to the chimeric antigen receptor T-cell therapy obecabtagene autoleucel (obe-cel; AUCATZYL) for adults ages 26 and older with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
The EC approval applies to all 27 European Union Member States, Iceland, Norway and Liechtenstein. Obe-cel is currently approved by the US Food and Drug Administration (FDA) and authorized by the UK Medicines and Healthcare products Regulatory Agency. The FDA approval was granted in November 2024.
“We believe AUCATZYL represents an important new treatment option for physicians treating adult [relapsed or refractory] B-ALL patients. With the EU marketing authorization, we are now evaluating market entry opportunities in EU countries,” Christian Itin, MD, Autolus CEO, said in a company release announcing the approval. Autolus, which has headquarters in Rockville, Maryland, is the manufacturer of obe-cel.
The approval was based on data from the pivotal FELIX trial, an open-label, multicenter, single arm study, and the results were published in November 2024 in The New England Journal of Medicine. The lead author of that study was Claire Roddie, MD, of the University College London.
Autolus partnered with AGC Biologics Milan in 2020 to produce the viral vectors needed to manufacture obe-cel for commercial use.
“This EC approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry’s safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization,” said Alberto Santagostino, CEO of AGC Biologics.
For the AGC Biologics’ Milan site, the EC approval mark the site’s tenth regulatory approval, according to the company’s press release.
