The U.S. Food and Drug Administration (FDA) has granted marketing approval to Autolus Therapeutics' AUCATZYL (obe-cel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This approval marks a significant advancement in the treatment landscape for this aggressive hematologic malignancy.
The FDA's decision was primarily based on data from the pivotal FELIX clinical trial, which evaluated the efficacy and safety of obe-cel in adult patients with r/r B-ALL. The trial demonstrated clinically meaningful and statistically significant improvements in key endpoints, supporting the drug's approval.
Manufacturing and Global Regulatory Status
AUCATZYL will be manufactured at Autolus' dedicated commercial manufacturing site, the Nucleus, located in Stevenage, UK. This facility is designed to ensure consistent and high-quality production of the cell therapy product.
Autolus is also pursuing regulatory approvals for obe-cel in other regions. Marketing authorization applications (MAAs) for obe-cel in adult r/r ALL are currently under review by regulatory authorities in both the European Union and the United Kingdom. The European Medicines Agency (EMA) accepted the submission in March 2024, and the UK MHRA accepted the submission in August 2024.
