Aucatzyl FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 12, 2024.
FDA Approved: Yes (First approved November 8, 2024)
Brand name: Aucatzyl
Generic name: obecabtagene autoleucel
Dosage form: Suspension for Intravenous Infusion
Company: Autolus Therapeutics plc
Treatment for: Acute Lymphoblastic Leukemia
Aucatzyl (obecabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- Acute lymphoblastic leukemia (ALL) is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs.
- Aucatzyl is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy. It is made from the patient's own white blood cells, which have been genetically modified to recognize and attack the leukemic cells.
- FDA approval for Aucatzyl was based on results of the FELIX clinical trial in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The major efficacy outcome was complete remission within 3 months, which was achieved in 42% patients, and the median duration of remission (DOR) was 14.1 months.
- Aucatzyl is administered via intravenous infusion following a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide.
- Aucatzyl is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy).
- Aucatzyl carries a Boxed Warning for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and secondary hematological malignancies.
- Warnings and precautions associated with Aucatzyl include prolonged cytopenias, severe infections, hypogammaglobulinemia and B-cell aplasia, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), and serious hypersensitivity reactions.
- Common adverse reactions (incidence ≥ 20%) include CRS, infections, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.
Development timeline for Aucatzyl
| Date | Article |
|---|---|
| Nov 8, 2024 | Approval FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia |
Further information
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