Difference between revisions of "Bosutinib (Bosulif)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2012-09-04: Initial approval for the treatment of adult patients with chronic, accelerated, or blast phase [[Biomarkers#BCR-ABL1|Ph+]] [[Chronic_myeloid_leukemia|chronic myelogenous leukemia (CML)]] with resistance or intolerance to prior therapy. ''(Based on Study 200)'' |
| − | *12 | + | *2017-12-19: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-bosutinib-treatment-newly-diagnosed-ph-cml Accelerated approval] for treatment of patients with newly-diagnosed chronic phase (CP) [[Biomarkers#BCR-ABL1|Philadelphia chromosome positive (Ph+)]] [[Chronic_myeloid_leukemia|chronic myelogenous leukemia (CML)]]. ''(Based on [https://clinicaltrials.gov/ct2/show/NCT02130557 BFORE])'' |
| − | ** | + | **2021-05-14: Converted to regular approval. ''(Based on BFORE)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2013-03-27: Initial authorization |
| + | ==History of changes in Health Canada indication== | ||
| + | *2014-03-07: Initial notice of compliance with conditions for the treatment of chronic, accelerated, or blast phase [[Biomarkers#BCR-ABL1|Ph+]] [[Chronic_myeloid_leukemia|CML]] in adult patients with resistance or intolerance to prior tyrosine kinase inhibitor therapy, and for whom subsequent treatment with imatinib, nilotinib, and dasatinib is not clinically appropriate. | ||
| + | *2017-08-02: Conditions were met | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' SKI-606 | *'''Code name:''' SKI-606 | ||
| Line 41: | Line 44: | ||
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
[[Category:EMA approved in 2013]] | [[Category:EMA approved in 2013]] | ||
| + | [[Category:Health Canada approved in 2014]] | ||
Revision as of 17:35, 29 March 2023
General information
Class/mechanism: Third-generation tyrosine kinase inhibitor of Bcr-Abl, the constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality in CML. Also inhibits kinases in the Src family, including Src, Lyn, and Hck. Active against many imatinib-resistant mutations (16 of 18 imatinib-resistant forms of Bcr-Abl in murine myeloid cell lines), but not active against the T315I and V299L mutations.[1][2][3][4]
Route: PO
Extravasation: n/a
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, Medscape, UpToDate (courtesy of Lexicomp), or the package insert.[1]
Diseases for which it is used
Patient drug information
- Bosutinib (Bosulif) package insert[1]
- Bosutinib (Bosulif) patient drug information (Chemocare)[5]
- Bosutinib (Bosulif) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2012-09-04: Initial approval for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. (Based on Study 200)
- 2017-12-19: Accelerated approval for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). (Based on BFORE)
- 2021-05-14: Converted to regular approval. (Based on BFORE)
History of changes in EMA indication
- 2013-03-27: Initial authorization
History of changes in Health Canada indication
- 2014-03-07: Initial notice of compliance with conditions for the treatment of chronic, accelerated, or blast phase Ph+ CML in adult patients with resistance or intolerance to prior tyrosine kinase inhibitor therapy, and for whom subsequent treatment with imatinib, nilotinib, and dasatinib is not clinically appropriate.
- 2017-08-02: Conditions were met
Also known as
- Code name: SKI-606
- Brand name: Bosulif
References
- ↑ 1.0 1.1 1.2 Bosutinib (Bosulif) package insert
- ↑ Bosutinib (Bosulif) package insert (locally hosted backup)
- ↑ Bosulif manufacturer's website
- ↑ ASCO Post 2/15/2012: BELA Trial Reborn: Bosutinib Produces Improved Results in Chronic Myeloid Leukemia
- ↑ Bosutinib (Bosulif) patient drug information (Chemocare)
- ↑ Bosutinib (Bosulif) patient drug information (UpToDate)