The U.S. FDA has approved Autolus Therapeutics' obecabtagene autoleucel, branded Aucatzyl, a CD19-directed genetically modified autologous T-cell immunotherapy for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The milestone approval, which marks Autolus' first commercial product, offers new hope for patients with this aggressive cancer once they relapse. Aucatzyl is to be administered as a split dose infusion on day 1 and day 10 (±2 days) based on bone marrow blast assessment and preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy. The approval is based on the FELIX clinical trial, where 42% of patients achieved complete remission within three months, and the median duration of remission was 14.1 months. According to Autolus, Aucatzyl showed low cytokine release syndrome (CRS) levels — a common and serious side effect of CAR-T therapy — with 3% grade 3 events and no grade 4 or 5 events. Like other CAR-T products, Aucatzyl has a boxed warning for CRS, neurologic toxicities, and secondary hematological malignancies. Aucatzyl does not have a REMS requirement, reducing ongoing reporting obligations. The move aligns with the agency's efforts to reduce the burden on the healthcare delivery system related to CAR-T therapies. Back in June, the FDA modified the REMS for several approved CAR-T therapies, removing requirements for educational and training materials as well as the requirement to report adverse events suggestive of CRS or neurological toxicities. According to Autolus, marketing authorization applications for obe-cel in adult r/r ALL are being reviewed by the regulators in both the EU and the UK, with a submission to the EMA accepted in March 2024, and a submission accepted by the UK MHRA in August 2024.
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