Vorinostat (Zolinza)
General information
Class/mechanism: Histone deacetylase (HDAC) inhibitor. Vorinostat inhibits histone deacetylases HDAC1, HDAC2, and HDAC3 (Class I), as well as HDAC6 (Class II). 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][3]
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, or the prescribing information.[1]
Patient drug information
- Vorinostat (Zolinza) manufacturer's patient drug information[4]
- Vorinostat (Zolinza) patient drug information (Chemocare)[5]
- Vorinostat (Zolinza) patient drug information (UpToDate)[6]
Diseases for which it is used
- Chronic myelomonocytic leukemia
- Cutaneous T-cell lymphoma
- Diffuse large B-cell lymphoma
- Graft versus host disease
- Indolent lymphoma
- Multiple myeloma
- Myelodysplastic syndrome
Diseases for which it was used
History of changes in FDA indication
- 2006-10-06: Initial FDA approval: treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. (Based on Duvic et al. 2006 & Merck 0683-001)
History of changes in EMA indication
- 2010-09-20: Orphan designation for the treatment of malignant mesothelioma.
- 2013-03-12: Orphan designation withdrawn.
History of changes in Health Canada indication
- 2009-06-11: Initial notice of compliance
History of changes in PMDA indication
- 2011-07-01: Initial approval for the treatment of cutaneous T-cell lymphoma.
Also known as
- Brand name: Zolinza
References
- ↑ 1.0 1.1 Vorinostat (Zolinza) package insert
- ↑ Vorinostat (Zolinza) package insert (locally hosted backup)
- ↑ Zolinza manufacturer's site
- ↑ Vorinostat (Zolinza) manufacturer's patient drug information
- ↑ Vorinostat (Zolinza) patient drug information (Chemocare)
- ↑ Vorinostat (Zolinza) patient drug information (UpToDate)
- Drugs
- Oral medications
- HDAC inhibitors
- Chronic myelomonocytic leukemia medications
- Cutaneous T-cell lymphoma medications
- Diffuse large B-cell lymphoma medications
- Graft versus host disease medications
- Indolent lymphoma medications
- Multiple myeloma medications
- Myelodysplastic syndrome medications
- Acute myeloid leukemia medications (historic)
- Classical Hodgkin lymphoma medications (historic)
- FDA approved in 2006
- EMA approved in 2010
- EMA withdrawn in 2013
- Health Canada approved in 2009
- PMDA approved in 2011