Bayer HealthCare announced last week that its new mesothelin-targeting antibody-drug conjugate (ADC) has been given orphan drug designation by the U.S. Food and Drug Administration (FDA) for use in the treatment of asbestos-caused mesothelioma cancer.
Currently, the drug – known as BAY 94-9343 – is in the midst of being tested by means of Phase I clinical trials. Bayer started drafting patients for the study nearly a year ago and the trials are taking place in three different U.S. study centers at this time, one each in Texas, Maryland, and Tennessee. The Phase I trial will assist in determining the safety and tolerability of the drug and will evaluate the pharmakinetics and pharmacodynamics of BAY 94-9343 in the treatment of individuals with advanced solid tumors, the company explained in a recent press release.
Professor Andreas Busch, a member of the Bayer HealthCare Executive Committee and the Head of Global Drug Discovery, called the orphan drug designation an important step in the development of this drug, which can potentially assist thousands of malignant mesothelioma patients each year if the trials are successful.
“Malignant mesothelioma is a rare type of cancer with a poor prognosis,” Busch explained. “There is a significant unmet medical need in this patient population for new treatment options. Bayer is committed to develop therapies that can help people with cancer live longer and improve their quality of life.”
Currently, there is only one drug on that market that is approved by the FDA specifically for the treatment of mesothelioma. That is Eli Lily’s drug known as ALIMTA®. As chemotherapy drugs are concerned, it has shown the most promise in the treatment of mesothelioma cancer, and though much progress has been made in the last decade in the realm of new treatments, scientists, researchers, and medical professionals all agree that there’s a long way to go towards finding therapies that do a better job of addressing the disease.