Table 1.
Axicabtagene ciloleucel background information.
Pharmacological class | CD19-directed, genetically-modified autologous T-cell immunotherapy |
Mechanism of action | Following anti-CD19 CAR T-cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T-cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to apoptosis and necrosis of CD19-expressing target cells. |
Pharmacokinetics in FL | Following infusion, axicabtagene ciloleucel exhibited an initial rapid expansion phase, achieving maximal expansion 8 days following infusion and persisting in the peripheral blood for a median of 6 months. Cytokine and chemokine levels peaked within the first 14 days and generally returned to baseline within 28 days. |
Approval in FLa | For the treatment of adult patients with relapsed or refractory FL after 2 or more lines of systemic therapy (2021) |
Other approvals | For the treatment of adult patients with relapsed or refractory largeB-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from FL (2017). Limitations of use: not indicated for the treatment of patients with primary central nervous system lymphoma. |
Under accelerated approval.
Abbreviation: FL, follicular lymphoma.