FDA Approves Aucatzyl for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Autolus Therapeutics plc has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Aucatzyl (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
- Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy.
- Aucatzyl is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy).
- ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs.
Source: Autolus Therapeutics plc
