Istodax

Treatment for Cutaneous T-cell Lymphoma

Update: Istodax (romidepsin) Now FDA Approved - November 5, 2009

FDA Advisory Committee Meeting to Discuss Romidepsin NDA

Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug 17, 2009 - 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.

About Romidepsin

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.

About Gloucester Pharmaceuticals

Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, romidepsin, a novel histone deacetylase (HDAC) inhibitor, is in late-stage development for T-cell lymphomas and has shown activity across a range of hematologic malignancies. A New Drug Application for romidepsin in cutaneous T-cell lymphoma (CTCL) is under review with the Food and Drug Administration (FDA) and a Prescription Drug User Fee Act (PDUFA) date of November 12, 2009 has been set. The Company is currently enrolling patients in a registration trial for peripheral T-cell lymphoma (PTCL) and is evaluating romidepsin in multiple additional indications including multiple myeloma. For more information, please visit www.gloucesterpharma.com.

Contact: MacDougall Biomedical Communications

Sarah Cavanaugh, 781-235-3060

Posted: August 2009

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