Difference between revisions of "Moxetumomab pasudotox (Lumoxiti)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*9/13/2018: Initial FDA 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)'' | *9/13/2018: Initial FDA 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== | |
| + | *2/8/2021: Initial authorization for treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies. | ||
| + | *7/23/2021: Authorization withdrawn at manufacturer request, for commercial reasons | ||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' moxetumomab pasudotox-tdfk | *'''Generic name:''' moxetumomab pasudotox-tdfk | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
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[[Category:Immunotoxin]] | [[Category:Immunotoxin]] | ||
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[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2021]] | ||
| + | [[Category:EMA withdrawn in 2021]] | ||
Revision as of 12:09, 3 January 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
- 9/13/2018: Initial FDA 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
- 2/8/2021: Initial authorization for treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies.
- 7/23/2021: Authorization withdrawn at manufacturer request, for commercial reasons
Also known as
- Generic name: moxetumomab pasudotox-tdfk
- Code names: CAT-8015, HA22
- Brand name: Lumoxiti