Developed by Autolus Therapeutics, AUCATZYL is now approved to treat adult patients (aged 26 and older) in 27 European Union member states with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL).
This follows the therapy’s prior authorisations from the FDA in November 2024 and the UK Medicines and Healthcare products Regulatory Agency in April 2025.
This latest step further solidifies AGC Biologics’ Milan Cell and Gene Center of Excellence’s reputation as a global leader in the field, built on a 30-year track record of quality, reliability and regulatory success.
“This European approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry’s safe harbour: a trusted, friendly expert CDMO that de-risks the complex path to commercialisation,” said Alberto Santagostino, CEO and President, AGC Biologics.
“By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients. Congratulations to the entire Autolus team.”
The partnership between Autolus and AGC Biologics Milan began in 2020, with the CDMO tasked with developing, manufacturing and supplying the viral vectors for Autolus’ obe-cel CAR-T product candidate.
“From the start of our partnership in 2020, through the FDA approval and now this European authorisation, our collaboration with Autolus has been a model of true partnership,” said Luca Alberici, General Manager, AGC Biologics Milan.
“The team’s sustained dedication and technical excellence are a direct result of our ability to work seamlessly with the Autolus team to meet the demands of commercial-scale manufacturing for a global market.”
With its 30-year track record and 10 product approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects.
The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up.