Personalized Medicine for Mesothelioma Patients Gets Boost From the FDA
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.”
“I have made it a priority to continue to evolve FDA’s regulatory processes in response to—and in anticipation of—scientific developments that are critical for the development of personalized therapeutics and diagnostics,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs in the Commissioner’s Message introducing the report.
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.
Less than seven percent of lung cancer patients are ALK-positive, and an unknown number of mesothelioma patients potentially express the abnormal ALK gene and may benefit from crizotinib.
Mesothelioma, a rare, asbestos-caused cancer, is diagnosed in close to 3,000 Americans each year. There is no cure for the cancer, and there are limited options available for treating patients.
“The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research when announcing the approval. “Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”
The FDA “will continue to facilitate the development of personalized medicine by advancing the science and tools that will help drive innovation, collaborating with scientists worldwide in important research activities, and providing guidance to industry to help shepherd new products through regulatory review.”
FDA Helping to Advance Treatments Tailored to You
FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer
Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development