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New Mesothelioma Drug Seeks Orphan Drug Status A company that makes stem cell-based cancer therapies has applied for orphan drug status to help develop and market a new mesothelioma drug. The biopharmaceutical company Verastem, Inc. specializes in drugs that shrink tumors by destroying cancer stem cells. VS-6063, an oral small molecule inhibitor of focal adhesion kinase (FAK), is one of its lead drugs. In a Phase I study of VS-6063 in 36 mesothelioma patients, the drug proved effective enough to warrant further study. A larger investigation of VS-6063 for mesothelioma is set to begin later this year. In the meantime, Verastem says it will seek orphan drug designation in the U.S. and the European Union for VS-6063. Orphan drug status is available for drugs developed for the treatment of diseases affecting fewer than 200,000 people in the U.S. The European Union requires that an orphan drug be one that treats diseases affecting no more than 5 in 10,000 people. The goal of orphan drug status is to provide incentives for companies to develop drugs for rare diseases like mesothelioma, for which few effective treatment area available. Orphan drug status can also help to smooth the path to market and make them available to patients faster. According to the FDA, the Office of Orphan Products Development has supported the development of more than 400 drugs and biologic products for rare diseases since 1983. VS-6063 is currently in testing for ovarian cancer. If Verastem receives orphan drug designation for VS-6063, the company could be eligible for grants to help develop the drug, tax credits for certain clinical trial expenses, and reduced regulatory fees. If the drug is approved, Verastem would also be granted exclusive rights to market VS-6063 for mesothelioma in the U.S. for 7 years and for 10 years in EU countries. About half of mesothelioma patients are believed to be more susceptible to FAK inhibitors like VS-6063 because they are missing a particular tumor suppressor. Verastem is working with LabCorp, Inc. to develop a test that identify these mesothelioma patients as eligible participants in the upcoming clinical trial. VS-6063 is already being tested for ovarian cancer.

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