Difference between revisions of "Nelarabine (Arranon)"
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*2007-09-22: Initial notice of compliance with conditions for use in the treatment of patients with [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]] whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. | *2007-09-22: Initial notice of compliance with conditions for use in the treatment of patients with [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]] whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. | ||
*2020-01-22: Conditions were met | *2020-01-22: Conditions were met | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2007-10-19: Initial approval for the treatment of relapsed or refractory [[T-cell acute lymphoblastic leukemia |T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' 506U78 | *'''Code name:''' 506U78 | ||
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[[Category:EMA approved in 2007]] | [[Category:EMA approved in 2007]] | ||
[[Category:Health Canada approved in 2007]] | [[Category:Health Canada approved in 2007]] | ||
| + | [[Category:PMDA approved in 2007]] | ||
Revision as of 00:47, 11 June 2023
General information
Class/mechanism: Purine analog, antimetabolite. Nelarabine is metabolized to the cytotoxic deoxyguanosine analogue, 9-β-Darabinofuranosylguanine (ara-G), which is eventually converted to ara-GTP. ara-GTP is incorporated into DNA and leads to inhibition of DNA synthesis and cell death.[1][2]
Route: IV
Extravasation: neutral
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
Patient drug information
- Nelarabine (Arranon) package insert PDF pages 17-19[1]
- Nelarabine (Arranon) patient drug information (Chemocare)[3]
- Nelarabine (Arranon) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2005-10-28: Accelerated approval for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (Based on Berg et al. 2005 and CALGB 19801)
- 2019-07-31: Converted to regular approval for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (Based on COG AALL0434)
History of changes in EMA indication
- 2007-08-22: Initial authorization as Atriance
History of changes in Health Canada indication
- 2007-09-22: Initial notice of compliance with conditions for use in the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
- 2020-01-22: Conditions were met
History of changes in PMDA indication
- 2007-10-19: Initial approval for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Also known as
- Code name: 506U78
- Brand names: Arranon, Atriance