|New Orphan Drug Approved for Mesothelioma|
Citing what it calls “unmet medical needs” among people with mesothelioma, Bayer HealthCare has announced an important step forward for its investigational cancer drug, BAY 94-9343. The drug, which is a mesothelin-targeting antibody-drug conjugate (ADC) has been granted orphan drug status by the Food and Drug Administration for the treatment of mesothelioma.
Antibody-drug conjugates, also called immunoconjugates or immunotoxins, are a new class of therapies that combine the targeting properties of an antibody with a cell-destroying “payload” drug. In the case of BAY 94-9343, the antibody portion of the medication targets the compound mesothelin, which is highly expressed by mesothelioma and several other cancers. According to a press release from Bayer HealthCare, BAY 94-9343 “demonstrated potent, targeted anti-cancer activity against mesothelin-expressing tumors in preclinical models.”
Orphan drug status is designed to encourage the development of drugs that are used to diagnose, treat or prevent rare diseases like mesothelioma, for which few viable treatment options exist. Mesothelioma is one of the rarest cancers, claiming the lives of about 2,500 Americans each year. The makers of orphan drugs are eligible for tax credits for clinical trial expenses and may be exempt from certain FDA fees. Bayer HeatlhCare will also have exclusive rights in the U.S. to market BAY 94-9343 for the treatment of mesothelioma. The hope is that orphan drug status will allow drugs like BAY-94-9343 to get to market faster
Bayer began testing the safety and efficacy of BAY 94-9343 for mesothelioma and other solid tumors in September 2011. Mesothelioma patients and those with other types of mesothelin-expressing tumors are currently being treated at three study centers in the U.S. More information about the BAY 94-9343 trials and other ongoing clinical trials for mesothelioma can be found at the National Cancer Institute clinical trials website.