Background

Aucatzyl (obecabtagene autoleucel) is a genetically modified autologous T cell immunotherapy indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The patient’s own T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill cancer cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells (1).

Regulatory Status

FDA-approved indications: Aucatzyl 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 (ALL) (1).

Aucatzyl has a boxed warning for cytokine release syndrome (CRS), immune effector cell[1]associated neurotoxicity syndrome (ICANS), and T cell malignancies. Patients with an active infection or inflammatory disorders should not receive Aucatzyl and monitoring for neurological events should be done after treatment of Aucatzyl. T cell malignancies have occurred following treatment of hematological malignancies with genetically modified immunotherapies (1).

Serious infections, including life-threatening or fatal infections, occurred in patients after Aucatzyl infusion. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, and hepatic failure, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing (1).

The safety and effectiveness of Aucatzyl have not been established in pediatric patients (1).

Aucatzyl may be considered medically necessary if the conditions indicated below are met.

Aucatzyl may be considered investigational for all other indications.

Prior-Approval Requirements

Age 18 years of age or older

Diagnoses

Patient must have the following:

B-cell precursor acute lymphoblastic leukemia (ALL)

1. Patient has ONE of the following:

a. Primary refractory ALL, first relapse following a remission lasting ≤ 12 months

b. Relapsed or refractory ALL after two or more lines of systemic therapy

c. Relapsed or refractory ALL greater than 3 months after allogeneic stem cell transplantation (HSCT)

2. Documentation of CD19 tumor expression in bone marrow or peripheral blood

3. Philadelphia chromosome-positive (Ph+) ALL only: patient must have received 2 lines of tyrosine kinase inhibitor (TKI) therapy

4. Lymphoblasts ≥ 5%

a. Patient has adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis

AND NONE of the following:

1. Burkitt lymphoma

2. Active significant graft-versus-host disease

3. Concomitant genetic syndrome associated with bone marrow failure

4. Received immunosuppressive medications within 4 weeks prior to treatment with Aucatzyl

5. Isolated extramedullary disease

6. Received allogeneic cellular therapy, such as donor lymphocyte infusion, within six weeks prior to Aucatzyl infusion

7. History of any CNS disorders, including CNS-2 disease with neurologic changes and CNS-3 disease irrespective of neurological changes

8. Active infections requiring systemic antimicrobial treatment

9. Active or latent infection with HBV or HCV

10. HIV, human T-cell lymphotropic virus (HTLV)-1, HTLV-2, or syphilis positive test

11. Prior therapy with any other gene therapy (e.g., Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta)

12. Dual therapy with any other gene therapy (e.g., Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta)

AND ALL of the following:

1. Prescriber agrees to monitor the patient for signs and symptoms of cytokine release syndrome (CRS) and administer tocilizumab if needed

2. Prescriber agrees to monitor the patient for signs and symptoms of neurological toxicities

3. Prescriber agrees to monitor for Hemophagocytic Lymphohistiocytosis/Macrophage activation Syndrome and treat per institutional standards

Prior – Approval Renewal Requirements

None

Pre – PA Allowance

None

Prior - Approval Limits

Quantity One infusion (only one PA approval for one infusion per lifetime)