Doctors and researchers have long touted the benefits of personalized medicine – establishing a treatment plan based on a patient’s specific disease characteristics and needs – for mesothelioma patients.
Treatment targeted to the patient’s particular traits optimizes the potential for success of the treatment, limits experimental treatments, and provides the patient with the assurance that his physician is not taking a “cookie-cutter” approach to his mesothelioma care.
Although the use of biomarkers in the area of mesothelioma is a relatively new but promising area of genetic research, some breakthroughs have allowed researchers to target specific genetic mutations to guide them towards new, effective mesothelioma treatments. Now, the U.S. Food and Drug Administration is undertaking “unique responsibilities” in facilitating the advancement of personalized medicine.
In an Oct. 29 article, the FDA announced the release of its report, “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development,” where the FDA commits to personalized medicine by focusing on advancing regulatory science. According to the FDA, regulatory science is “the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”
In the last few years, the FDA has approved a variety of personalized treatments “that signal a new era of medical product development have entered the market or come on the horizon.” Specifically, the FDA has approved four cancer drugs for use in patients whose tumors have specific genetic characteristics. In August 2011, the FDA approved crizotinib (Xalkori) along with an ALK FISH probe companion diagnostic to treat patients with late-stage, non-small cell lung cancers who express the abnormal anaplastic lymphoma kinase (ALK) gene.