Initial US Approval:
2024
Key Clinical Studies:
FELIX (NCT04404660)
Drug Class/Description:
CD19-directed genetically modified autologous T cell immunotherapy
Indications and Usage:
The treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Dosage Administration:
For autologous use only. For intravenous use only.
Do NOT use a leukodepleting filter.
Prior to infusion:
- Administer a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide.
- Ensure availability of bone marrow assessment results from a sample obtained within 7 days prior to start of lymphodepleting chemotherapy.
- Premedicate with acetaminophen.
- Confirm availability of tocilizumab prior to infusion.
AUCATZYL Dose and Administration
- Verify patient’s identity prior to infusion.
- Dosing is based on the Dose Schedule Planner.
- The total recommended dose of AUCATZYL is 410 × 106 CD19 chimeric antigen receptor (CAR)-positive viable T cells.
- The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days) (2.1). Dose to be administered is determined by the patient bone marrow blast assessment.
- See Full Prescribing Information for important preparation and administration information.
Dosage Forms and Strengths:
AUCATZYL is a cell suspension for infusion.
AUCATZYL contains a total recommended dose of 410 x 106 CD19 CAR-positive viable T cells supplied in 3 to 5 infusion bags.
Contraindications:
None.
Warnings and Precautions:
Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following AUCATZYL infusion. Monitor complete blood counts.
Infections: Monitor patients for signs and symptoms of infection; treat appropriately.
Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy
Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome: Administer treatment per institutional standards.
Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion.
Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. In the event that a secondary malignancy occurs after treatment with AUCATZYL, contact Autolus Inc at 1-855-288-5227.
Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks after receiving AUCATZYL.
Adverse Reactions:
The most common (non-laboratory) adverse reactions (incidence ≥ 20%) are: CRS, infections - pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.
Adapted from:
https://www.fda.gov/media/183463/download?attachment
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
