Approved November 5, 2009

ROMIDEPSIN
(FDA Category 1)

ISTODAX(R) (Gloucester Pharmaceuticals, Inc.) is a histone deacetylase (HDAC) inhibitor which catalyzes the removal of acetyl groups from acetylated lysine residues in histones which results in gene expression modulation. Additionally, non-histone proteins are deacetylated by HDAC. The exact antineoplastic mechanism of action is not yet fully understood.

DOSING INFORMATION: The recommended dose is 14 milligrams/meter(2) intravenously over 4 hours on days 1, 8, and 15 of a 28day cycle. Repeat cycles every 28 days as long as patient continues to tolerate and benefit from therapy.

CAUTIONS: No contraindications have been identified. Use with caution in women of childbearing potential, pregnant women, patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and in patients taking medicinal products that may significantly prolong the QT interval. It is important that potassium and magnesium levels are in the normal range prior to administration of romidepsin and hematological parameters should be monitored during treatment. The most common adverse reactions associated with romidepsin therapy are nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia, and lymphopenia.

FDA APPROVED INDICATIONS: Romidepsin is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.