Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2017-08-17: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm | + | *2017-08-17: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm Approved] for the treatment of adults with relapsed or refractory [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. ''(Based on INO-VATE ALL)'' |
==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 Health Canada indication== | ||
| + | *2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]]. | *2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]]. | ||
| Line 46: | Line 48: | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
[[Category:PMDA approved in 2018]] | [[Category:PMDA approved in 2018]] | ||
[[Category:Pfizer product]] | [[Category:Pfizer product]] | ||
Revision as of 15:43, 15 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: 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 Health Canada indication
- 2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
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
References
Categories:
- Drugs
- Intravenous medications
- Antibody-drug conjugates
- Anti-CD22 antibodies
- Enediyne antibiotic
- B-cell acute lymphoblastic leukemia medications
- Follicular lymphoma medications
- Diffuse large B-cell lymphoma medications (historic)
- EMA approved in 2017
- FDA approved in 2017
- Health Canada approved in 2018
- PMDA approved in 2018
- Pfizer product