Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

CTCL is a type of non-Hodgkin's lymphoma, which is a cancer of the immune system. CTCL is caused by a mutation of T cells, unlike most non-Hodgkin's lymphomas which are generally of B-cell origin. The malignant T cells involve the skin, causing plaques, patches, erythroderma and/or tumors and can involve other organs, including the blood lymph nodes and viscera. Romidepsin has received Orphan Drug Designation from the Food and Drug Administration (FDA) for the treatment of non-Hodgkin’s T-cell lymphomas, including CTCL. A New Drug Application for romidepsin in CTCL is under review with the FDA and a Prescription Drug User Fee Act (PDUFA) date of November 12, 2009 has been set.

Romidepsin’s cyclic peptide structure is novel among members of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDAC inhibition has been shown to increase acetylation of histones and other proteins. The downstream effects of HDAC inhibition include growth inhibition, apoptosis, inhibition of angiogenesis and differentiation. Nonclinical studies suggest that romidepsin is a pan-HDAC inhibitor and is a potent inhibitor of Class I, Class II and Class IV HDACs.

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