Gloucester Receives FDA Approval For Istodax

The FDA has approved Gloucester Pharmaceuticals’ Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL), in patients who have received at least one prior systemic therapy. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. It is expected to be commercially available in January 2010.

The company said that the approval of Istodax was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response. The New Drug Application (NDA) included efficacy data from two studies encompassing 167 patients.

Jean Nichols, president and chief operating officer of Gloucester, said: “The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials. Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”

Alan Colowick, CEO of Gloucester, said: “The approval of Istodax is a tremendous accomplishment for Gloucester Pharmaceuticals and for the patients we serve. This milestone is also an important step in the continued clinical development path for Istodax in oncology. We look forward to presenting data from our registration study of Istodax in peripheral T-cell lymphoma in 2010 and continuing further investigation in additional hematologic indications and solid tumors.”