FDA approves treatment for cutaneous T-cell lymphoma

Submitted by Ross Bonander Sun 11/22/2009

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Earlier this month, the US FDA approved the antibiotic histone deacetylase inhibitor romidepsin (marketed as Istodax injection) for treating patients with cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.

The FDA first fast-tracked the antibiotic as a potential anti-cancer agent in the treatment of CTCL five years ago, in 2004.

The FDA’s approval follows the publication of two multicenter, single-arm studies, one sponsored by Gloucester Pharmaceuticals (makers of Istodax) and another sponsored by the National Cancer Institute.

There were a number of adverse events reported following the conclusion of each study, including nausea, fatigue, infections, vomiting, and anorexia, as well as anemia, thrombocytopenia, electrocardiogram T-wave changes, neutropenia, and lymphopenia.

By Ross Bonander

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