On November 8, 2024 Autolus, Inc. (“Autolus”) announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”). AUCATZYL is a CAR T cell therapy designed to specifically recognize and bind CD19-positive B-cells in precursor ALL patients. AUCATZYL is recommended for administration as a split dose infusion on Day 1 and Day 10 (±2 days, based on patient bone marrow blast assessment) following lymphodepleting chemotherapy treatment. The FDA’s new approval is based on results from a Phase Ib/II open-label, multi-center, single arm study (“FELIX,” NCT04404660) that measured rate and duration of complete remission achieved within 3 months of treatment. FELIX reported 27 of 65 evaluated patients achieved complete remission within 3 months, with a median complete remission duration of 14.1 months.
Autolus submitted AUCATZYL for FDA approval under the regenerative medicine advanced therapy designation and orphan drug designation. AUCATZYL represents Autolus’s first FDA approved CAR T cell therapy.
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