FDA gives Fast Track Status to possible Mesothelioma Treatment

The U. S. Food and Drug Administration (FDA) gave a ‘Fast Track’ status to a WT1 cancer vaccine. By receiving a Fast Track status this moves the vaccine closer to becoming the first approved second line treatment. The vaccine is for the treatment of malignant pleural mesothelioma and is also known as galinpepimut-S.

The vaccine is an immunotherapy agent which targets the WT1 protein. The WT1 protein is found in high levels in many cancers including mesothelioma. While the protein is present in cancer it is rarely found in normal adult cells. The WT1 protein is generally resistant to standard chemotherapy agents.

The vaccine was developed by the Sellas Life Sciences Group. A biopharmaceutical company based in Switzerland. The company focused on immunotherapeutic agents when developing the vaccine. The Sellas Life Sciences Group CEO, Dr. Angelos Stergiou said the treatment would lengthen the survival of patients with mesothelioma. Furthermore, he stated that the company was exploring all possible options to make the vaccine available as soon as possible.

First line treatment and FDA Fast Track Status

The standard first line of treatment for mesothelioma is a combination of chemotherapy, surgery and radiation. However, patients live less than two years after diagnosis so the therapeutic progress has come slowly.

It normally takes the FDA ten years or more to approve a drug. However, the Fast Track status allows the FDA to review and aid a drug in its development. The FDA focuses on drugs that treat an unmet need for serious and life threatening diseases.

Mesothelioma is a rare and aggressive cancer caused by exposure to asbestos fibers. Normally, it is as a result of years of exposure to asbestos through work related exposure or secondary exposure. In the U. S. alone, doctors diagnose about three thousand people with mesothelioma each year.