Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2017-06-28: Initial authorization | *2017-06-28: Initial authorization | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive [[:Category:Acute lymphoblastic leukemia|acute lymphoblastic leukemia]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CMC-544 | *'''Code name:''' CMC-544 | ||
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[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
[[Category:Pfizer product]] | [[Category:Pfizer product]] | ||
Revision as of 01:37, 9 June 2023
General information
Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. [1][2][3][4]
Route: IV
Extravasation: No information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information[1].
Diseases for which it is used
Diseases for which it was used
Patient drug information
- Inotuzumab ozogamicin (Besponsa) package insert[1]
- Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)[5]
History of changes in FDA indication
- 2017-08-17: FDA approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on INO-VATE ALL)
History of changes in EMA indication
- 2017-06-28: Initial authorization
History of changes in PMDA indication
- 2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive acute lymphoblastic leukemia.
Also known as
- Code name: CMC-544
- Brand name: Besponsa