FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma

Featured Article
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cancer / Oncology;  Lymphoma / Leukemia / Myeloma;  Blood / Hematology
Article Date: 12 Nov 2009 - 11:00 PST

email to a friend   printer friendly   view / write opinions   rate article

The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts.

Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma. It is a slow growing cancer that affects lymphocytes, a type of white blood cell that helps the body fight infection.

The cancer usually starts with dry skin and a red rash, and then itching that can be very severe and the skin can develop tumors that become ulcerated and then infected. In some cases the cancer spreads to the blood, lymph nodes and internal organs.

If a patient has localized CTCL they can be treated with topical agents such as special skin creams or with phototherapy, but if the cancer spreads then they usually need chemotherapy.

Istodax works by interfering with cell replication and is intended for patients whose CTCL has either got worse or has come back after having been treated with at least one other type of chemotherapy.

Istodax is the fourth drug to receive FDA approval for the treatment of CTCL. The other three are Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene).

The approval was granted on the evidence of two clinical studies involving 167 patients, of which about 35 per cent in both trials showed tumor responses where the tumors shrank. The responses lasted for a median of 15 months in one study and 11 months in the other.

6 per cent of the patients had complete responses where there was no evidence of tumors at all when they were examined physically, lab tested and X- rayed.

The drug's common side effects include "nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells," reported the FDA, and it may also cause changes in an electrocardiogram (ECG).

The FDA advises that:

"Periodic blood tests should be done to monitor electrolytes, and periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities."

They also pointed out that Istodax may harm a fetus and women should avoid becoming pregnant while they are taking the drug.

-- more information from Gloucester Pharmaceuticals press release.

Source: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today