Istodax Approved for Cutaneous T-Cell Lymphoma

The Gloucester Pharmaceuticals drug Istodax (romidepsin) has been approved by the U.S. Food and Drug Administration to treat cutaneous T-cell lymphoma (CTCL) in people who have tried at least one prior systemic therapy, the drug's manufacturer said in a news release.

CTCL is a form of non-Hodgkin's lymphoma, a cancer of the germ-fighting lymphatic system. The cancerous cells of the skin can cause itchy, disfiguring patches, and the cancer may involve other organs including the lymph nodes, blood and viscera, the drug maker said.

Blood parameters should be carefully monitored while people take Istodax, and since it can harm a fetus, the drug shouldn't be taken by pregnant women, Gloucester said. Istodax also may interfere will some contraceptives that contain estrogen, the company warned.

Approval of Istodax followed two clinical studies of 167 patients, Gloucester said. The drug is expected to be available in January.

More information

There's more about this drug's history at the FDA.

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