Idecabtagene vicleucel

ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

ABECMA is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

For autologous use only. For intravenous use only. • Do NOT use a leukodepleting filter. • Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion of ABECMA. • Confirm the patient's identity prior to infusion. • Premedicate with acetaminophen and an H 1 -antihistamine. • Avoid prophylactic use of dexamethasone or other systemic corticosteroids. • Confirm availability of tocilizumab prior to infusion. • Dosing of ABECMA is based on the number of chimeric antigen receptor (CAR)-positive T cells. • The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells.

None. None.

Boxed warning: Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. • Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. • Infections: Monitor patients for signs and symptoms of infection, treat appropriately. • Prolonged Cytopenias: Patients may exhibit prolonged Grade 3 or higher cytopenias following ABECMA infusion. Monitor blood counts prior to and after ABECMA infusion. • Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy.

The following adverse reactions are described elsewhere in the labeling: • Early Death • Cytokine Release Syndrome • Neurologic Toxicities • Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) • Hypersensitivity Reactions • Infections • Prolonged Cytopenias • Hypogammaglobulinemia The most common nonlaboratory adverse reactions (incidence ≥20%) include pyrexia, CRS, hypogammaglobulinemia, infections–pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections. The most common Grade 3 or 4 laboratory adverse reactions (incidence ≥50%) include leukocyte count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, and hemoglobin decreased.

Drug/Laboratory Test Interactions HIV and the lentivirus used to make ABECMA have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received ABECMA.

Store ABECMA frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).