September 28, 2009

FDA OK’s peripheral T-cell lymphoma drug

The U.S. Food and Drug Administration has approved Folotyn as the first treatment for a form of cancer known as peripheral T-cell lymphoma.

Folotyn (pralatrexate) was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs, officials said. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system, the FDA said. There are many types of lymphoma. One type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. Peripheral T-cell lymphoma, an often aggressive form of non-Hodgkin's disease, involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in fewer than 9,500 patients each year in the United States.

The FDA said its approval was based on evidence Folotyn reduces tumor size because tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extending the survival of cancer patients. Of 109 patients with the cancer in the trial, 27 percent had reduction in tumor size.

Folotyn is manufactured by Allos Therapeutics Inc. of Westminster, Colo.

As a condition of accelerated approval, the FDA said Allos will conduct studies to confirm tumor shrinkage actually does predict that patients will live longer.