Romidepsin: In the Treatment of T-Cell Lymphoma

• Published in: Drugs (New York, N.Y.) N.Y.), 2011-01, Vol.71 (11), p.1469-1480
• Main Author: Yang, Lily P. H.
• Format: Article
• Language: English
• Subjects: Adis Drug Profile; Adult; Aged; Aged, 80 and over; Antibiotics, Antineoplastic - adverse effects; Antibiotics, Antineoplastic - pharmacokinetics; Antibiotics, Antineoplastic - pharmacology; Antibiotics, Antineoplastic - therapeutic use; Antineoplastic agents; Biological and medical sciences; Chemotherapy; Depsipeptides - adverse effects; Depsipeptides - pharmacokinetics; Depsipeptides - pharmacology; Depsipeptides - therapeutic use; Drug therapy; Female; Health aspects; Histone Deacetylase Inhibitors - adverse effects; Histone Deacetylase Inhibitors - pharmacokinetics; Histone Deacetylase Inhibitors - pharmacology; Histone Deacetylase Inhibitors - therapeutic use; Humans; Infusions, Intravenous; Internal Medicine; Lymphoma, T-Cell, Cutaneous - drug therapy; Lymphoma, T-Cell, Cutaneous - physiopathology; Lymphoma, T-Cell, Peripheral - drug therapy; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Non-Hodgkin's lymphomas; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pharmacotherapy; Romidepsin; Treatment Outcome
• ISSN: 0012-6667; 1179-1950
• DOI: 10.2165/11207170-000000000-00000

Romidepsin is a histone deacetylase inhibitor with high inhibitory activity for class I histone deacetylases. Intravenous romidepsin is indicated in the US for the treatment of adult patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic therapy. The clinical efficacy of romidepsin has been demonstrated in two noncomparative, multicentre, phase II trials in patients with relapsed, refractory or advanced CTCL. In both trials, therapy with intravenous romidepsin was associated with an overall response (i.e. both complete response and partial response) rate of 34% and a complete response rate of 6%. The efficacy of romidepsin was also evaluated in patients with relapsed or refractory PTCL in two noncomparative, multicentre, phase II trials. Intravenous romidepsin therapy was associated with overall response rates of 38% and 26% and a complete response rate of 18% and 13% in these trials. Romidepsin had an acceptable tolerability profile in clinical trials in patients with CTCL or PTCL. The most common adverse events of grade 3 or 4 severity considered at least possibly related to romidepsin were haematological or asthenic in nature, and included leukopenia, lymphopenia, granulocytopenia, thrombocytopenia, fatigue and anaemia.