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In the Treatment of T-Cell Lymphoma


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.

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Acknowledgements and Disclosures

The manuscript was reviewed by: S.E. Bates, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA; C. Gisselbrecht, Institut d’Hématologie, Hôpital Saint Louis, Paris, France; R.L. Piekarz, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA; T. Robak, Department of Hematology, Medical University of Lodz, Lodz, Poland.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Lily P. H. Yang.

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Yang, L.P.H. Romidepsin. Drugs 71, 1469–1480 (2011). https://doi.org/10.2165/11207170-000000000-00000

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  • Vorinostat
  • Mycosis Fungoides
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  • Romidepsin
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