Use of romidepsin for the treatment of mycosis fungoides and Sezary syndrome - role of romidepsin in the current therapeutic landscape and implications for future practice

Introduction: Cutaneous T-cell lymphoma (CTCL) encompasses a rare group of hematologic malignancies, in which complete and durable responses to treatment are often elusive, with patients requiring multiple successive lines of therapy. Traditional chemotherapeutic agents do not seem to deliver lasting responses and are not without cumulative toxicity. In this context, focus has shifted to biologic and immunomodulatory agents, of which the histone deacetylase inhibitor (HDACi) romidepsin has attracted interest for its tolerability and proven efficacy in around one-third of patients in two pivotal clinical trials.Areas covered: In this review, we survey existing preclinical and clinical data for romidepsin from its discovery to use in prospective clinical trials. Pharmacology, toxicity and current market overview including potential comparators are also examined.Expert opinion: There is a clear and demonstrable role for romidepsin in the treatment of CTCL given convincing long-term Phase II efficacy data. Nonetheless, prospective data are lacking to guide selection between different biologic agents and to better identify those patients most likely to benefit from this therapy. We suggest that comparative trials between biologic agents, and ongoing research into CTCL pathogenesis and biomarkers of disease response are required to guide this decision-making process in future.