• Verastem Mesothelioma Treatment Receives FDA’s Orphan Drug Designation
  • April 7, 2015
  • Law Firm: Waters Kraus LLP - Dallas Office
  • Verastem, Inc., a company that works to develop drugs to treat mesothelioma and other cancers by killing cancer stem cells, has announced that the U.S. Food and Drug Administration has granted Verastem’s VS-5584 an orphan drug designation. VS-5584 may prove to be effective for treating mesothelioma, a rare cancer whose only confirmed cause is exposure to asbestos.
     
    The orphan drug designation was created to promote the development of drugs for treating patients with rare diseases, like mesothelioma. The Orphan Drug Act generally covers diseases affecting fewer than 200,000 American patients.

    Verastem reportedly had already received the orphan medicinal product designation in Europe. The drug maker has announced that it will bring its new mesothelioma drug to patients suffering with the asbestos disease as soon as possible.

    Verastem’s VS-5584 Now in Clinical Studies to Determine the Drug’s Usefulness for Treating Mesothelioma

    A phase 1 clinical trial is currently ongoing concerning a combination of Verastem’s VS-5584 and VS-6063 for patients with progressive or relapsed pleural mesothelioma. In another phase 1 study, VS-5584 is being tested for the treatment of advanced solid mesothelioma tumors. Some patients have participated in the trial for more than six months and have tolerated increasingly high doses of VS-5584 without serious harm.

    Mesothelioma: What Is It And Where Does It Strike?

    Mesothelioma is a rare and aggressive cancer that occurs in the body’s mesothelial tissue which lines the lungs and other organs. Approximately 3,000 Americans, including many U.S. veterans, are diagnosed with mesothelioma each year. The only approved pharmaceutical treatment for mesothelioma is Alimta (pemetrexed). But Alimta does not cure the disease. There is currently no approved therapy for relapsed mesothelioma.

    The hope is that Verastem’s VS-5584 will be able to reduce the percentage of cancer stem cells in mesothelioma patients and lead to tumor regression for patients with cancers that are resistant to chemotherapy, such as mesothelioma.