Romidepsin (Istodax)

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

Cutaneous T-cell lymphoma

Diseases for which it was used

Peripheral T-cell lymphoma

Patient drug information

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_CTCL 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Peripheral T-cell lymphoma - WITHDRAWN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Approval for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy withdrawn.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: FK-228, FR-901228, NSC-630176
Generic name: depsipeptide
Brand name: Istodax

References

[insert-1] 1.0 ^1.1 ^1.2 Romidepsin (Istodax) package insert

[2] Romidepsin (Istodax) package insert (locally hosted backup)

[3] Romidepsin (Istodax) patient drug information (UpToDate)

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[2]

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