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Gloucester’s Istodax Approved for Cutaneous T-cell Lymphoma

Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval was based on disease response defined as the number of patients with confirmed complete response or partial response. The NDA included efficacy data from two studies involving 167 patients. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) in...

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