ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a skin cancer that affects fewer than 20,000 people in the United States.
Gloucester Pharmaceuticals announced the FDA’s approval of Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma, a type of non-Hodgkin’s lymphoma also known as CTCL, in patients who have received at least one prior systemic therapy. The cancer affects between 16,000 and 20,000 people in the United States and is most common among men ages 50 years and older, according to the Cutaneous Lymphoma Foundation.
“CTCL is a devastating cancer in which many patients suffer from disfiguring tumors, horribly itchy and infected skin and, in advanced stages, lesions in other organs,” Stanford Cancer Center professor and Istodax clinical trial investigator Youn Kim stated. “Current systemic therapies have proved inadequate, and patients with CTCL desperately need treatment options that can offer sustained relief from their disease so they can live fuller lives.”