Gloucester Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved ISTODAX (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. 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. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.
“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,” said Youn Kim, MD, an investigator in studies of ISTODAX and Professor, Department of Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Program, Stanford Cancer Center, Stanford, CA. “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. ISTODAX meets a significant unmet need and provides hope for patients with CTCL, their families and their physicians.”
Paul A. Bunn, Jr., MD, James Dudley Chair in Cancer Research, Professor and Director, University of Colorado Cancer Center and past-President of the American Society of Clinical Oncology said, “ISTODAX offers physicians an important new treatment choice that can provide clinically meaningful, and, most importantly, sustainable responses for some patients with CTCL who have failed prior systemic therapy. Additionally, the approval of a second HDAC inhibitor in cancer is very exciting and speaks to the potential for this class of compounds.”
“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,” said Jean Nichols, PhD, President and Chief Operating Officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of ISTODAX.”
Alan Colowick, MD, Chief Executive Officer of Gloucester Pharmaceuticals 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.”
Date: November 6, 2009
Source: Gloucester Pharmaceuticals
