Difference between revisions of "Moxetumomab pasudotox (Lumoxiti)"
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| − | =Mechanism of action= | + | ==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) | 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] | + | *[[Hairy cell leukemia]] |
| − | |||
| − | |||
| − | =Also known as= | + | ==History of changes in FDA indication== |
| − | *'''Code | + | *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== | ||
| + | *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| + | *2021-07-23: Authorization withdrawn at manufacturer request, for commercial reasons | ||
| + | ==Also known as== | ||
| + | *'''Generic name:''' moxetumomab pasudotox-tdfk | ||
| + | *'''Code names:''' CAT-8015, HA22 | ||
| + | *'''Brand name:''' Lumoxiti | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Immunotoxin]] | [[Category:Immunotoxin]] | ||
| − | [[Category:Anti-CD22 | + | [[Category:Anti-CD22 immunotoxins]] |
[[Category:Hairy cell leukemia medications]] | [[Category:Hairy cell leukemia medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2018]] |
| + | [[Category:EMA approved in 2021]] | ||
| + | [[Category:EMA withdrawn in 2021]] | ||
Latest revision as of 22:29, 3 July 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