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news.Romidepsin, for the treatment of non-Hodgkin’s T-cell lymphomas, including CTCL
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Gloucester has reported that it 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.
Romidepsin’s cyclic peptide structure is novel among members of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors.
Romidepsin has received Orphan Drug Designation from the 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.