FDA Approves Gloucester Pharmaceuticals' ISTODAX® for Patients with Cutaneous T-cell Lymphoma


FDA Approves Gloucester Pharmaceuticals' ISTODAX® for Patients with Cutaneous T-cell Lymphoma

--Overall response rates exceeded primary endpoint in ISTODAX studies; sustained duration of response reported--

CAMBRIDGE, MA - November 5, 2009 - Gloucester Pharmaceuticals announced today 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.