Difference between revisions of "Moxetumomab pasudotox (Lumoxiti)"
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*2018-09-13: Initial approval for adult patients with relapsed or refractory [[Hairy cell leukemia|hairy cell leukemia (HCL)]] who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). ''(Based on Study 1053)'' | *2018-09-13: Initial approval for adult patients with relapsed or refractory [[Hairy cell leukemia|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== | ==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. | + | *2021-02-08: Initial authorization for treatment of adult patients with relapsed or refractory [[Hairy cell leukemia|hairy cell leukaemia (HCL)]] after receiving at least two prior systemic therapies. |
*2021-07-23: Authorization withdrawn at manufacturer request, for commercial reasons | *2021-07-23: Authorization withdrawn at manufacturer request, for commercial reasons | ||
==Also known as== | ==Also known as== | ||
Revision as of 00:27, 6 June 2023
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
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- 2021-07-23: Authorization withdrawn at manufacturer request, for commercial reasons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