Difference between revisions of "Romidepsin (Istodax)"
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==History of changes in Health Canada indication== | ==History of changes in Health Canada indication== | ||
*2013-10-16: Initial notice of compliance with conditions for the treatment of patients with relapsed/refractory [[Peripheral T-cell lymphoma |peripheral T-cell lymphoma (PTCL)]] who are not eligible for transplant and have received at least one prior systemic therapy. | *2013-10-16: Initial notice of compliance with conditions for the treatment of patients with relapsed/refractory [[Peripheral T-cell lymphoma |peripheral T-cell lymphoma (PTCL)]] who are not eligible for transplant and have received at least one prior systemic therapy. | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2017-07-03: New approval for the treatment of relapsed or refractory [[peripheral T-cell lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' FK228, FR901228, NSC 630176 | *'''Code names:''' FK228, FR901228, NSC 630176 | ||
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[[Category:FDA approved in 2009]] | [[Category:FDA approved in 2009]] | ||
[[Category:Health Canada approved in 2013]] | [[Category:Health Canada approved in 2013]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Revision as of 01:25, 9 June 2023
General information
Class/mechanism: Histone deacetylase (HDAC) inhibitor. HDACs normally catalyze removal of acetyl groups from acetylated lysine residues in histones and non-histone proteins, which helps to regulate gene expression. Inhibition of histone deacetylases results in hyperacetylation of histones and modulates gene expression by creating an open chromatin state that leads to expression of previously silenced genes. Although the mechanism of action is not fully understood, inhibiting HDACs has been observed to result in cell cycle arrest and apoptosis of cancer cells.[1][2]
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
- Romidepsin (Istodax) package insert PDF pages 8-9[1]
- Romidepsin (Istodax) patient drug information (UpToDate)[3]
History of changes in FDA indication
Cutaneous T-cell lymphoma
- 2009-11-05: Initial FDA approval for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. (Based on NIH 01-C-0049 and GPI-04-0001)
Peripheral T-cell lymphoma - WITHDRAWN
- 2011-06-16: Additional indication for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. (Based on GPI-06-0002)
- 2021-07-30: Approval for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy withdrawn. (Based on LYSA Ro-CHOP)
History of changes in Health Canada indication
- 2013-10-16: Initial notice of compliance with conditions for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy.
History of changes in PMDA indication
- 2017-07-03: New approval for the treatment of relapsed or refractory peripheral T-cell lymphoma.
Also known as
- Code names: FK228, FR901228, NSC 630176
- Generic name: depsipeptide
- Brand name: Istodax