Moxetumomab pasudotox (Lumoxiti)

Mechanism of action

A recombinant immunotoxin consisting of the Fv portion of the anti-CD22 antibody covalently fused to a 38 KDa fragment of Pseudomonas exotoxin-A (PE38)

Diseases for which it is used

• Hairy cell leukemia

History of changes in FDA indication

• 2018-09-13: Initial approval for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). (Based on Study 1053)

History of changes in EMA indication

• 2021-02-08: Initial authorization for treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies.
• 2021-07-23: Authorization withdrawn at manufacturer request, for commercial reasons

Also known as

• Generic name: moxetumomab pasudotox-tdfk
• Code names: CAT-8015, HA22
• Brand name: Lumoxiti