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) inhibitors and is expected to be commercially available in January 2010.
“The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials,” said Jean Nichols, Ph.D., president and chief operating officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”