The FDA has granted approval to Autolus Therapeutics' AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients battling relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This CAR-T cell therapy represents a significant advancement for patients with limited treatment options.
AUCATZYL is engineered to precisely target and bind to CD19-positive B-cells, which are characteristic of B-cell precursor ALL. The recommended administration involves a split dose infusion on Day 1 and Day 10 (±2 days, based on patient bone marrow blast assessment) following lymphodepleting chemotherapy.
The FDA's decision was primarily influenced by the outcomes of the Phase Ib/II FELIX trial (NCT04404660), an open-label, multi-center, single-arm study. The trial's primary endpoint focused on the rate and duration of complete remission achieved within 3 months of treatment. The FELIX trial reported that 27 out of 65 evaluated patients achieved complete remission within 3 months, translating to a 42% complete remission rate. The median duration of complete remission was 14.1 months.
Autolus pursued FDA approval for AUCATZYL under the regenerative medicine advanced therapy designation and orphan drug designation. This approval marks a pivotal moment for Autolus, representing their first FDA-approved CAR-T cell therapy.
