Difference between revisions of "Bosutinib (Bosulif)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*9/4/2012: Initial FDA approval for "the treatment of adult patients with [[Chronic_myelogenous_leukemia|chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML)]] with resistance or intolerance to prior therapy." | *9/4/2012: Initial FDA approval for "the treatment of adult patients with [[Chronic_myelogenous_leukemia|chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML)]] with resistance or intolerance to prior therapy." | ||
| + | *12/19/2017: Granted FDA accelerated approval for treatment of patients with newly-diagnosed chronic phase (CP) [[Chronic_myelogenous_leukemia|Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML)]]. | ||
==Also known as== | ==Also known as== | ||
Revision as of 00:54, 20 December 2017
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
Clinical trials
- BELA: Bosutinib (BOS) versus imatinib (IM) in patients (pts) with newly diagnosed chronic phase chronic myeloid leukemia (CP CML)
- Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias[5]
- Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Patient drug information
History of changes in FDA indication
- 9/4/2012: Initial FDA 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."
- 12/19/2017: Granted FDA accelerated approval for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).
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
- ↑ Khoury HJ, Cortes JE, Kantarjian HM, Gambacorti-Passerini C, Baccarani M, Kim DW, Zaritskey A, Countouriotis A, Besson N, Leip E, Kelly V, Brümmendorf TH. Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood. 2012 Apr 12;119(15):3403-12. Epub 2012 Feb 27. link to original article contains verified protocol PubMed