FDA to Regulate Personalized Medicine

Now that medical treatment is increasingly tailored to patient subtypes (eg, lung cancer patients with mutations in the ALK gene can be treated with Xalkori), the U.S. Food and Drug Administration (FDA) has released a new report explaining how it will regulate personalized therapies and tests. The first targeted therapy used in the U.S. was trastuzumab, which is for HER2 breast cancer and was approved in 1998. Since then, the FDA has approved more than 100 treatments that target specific genetic abnormalities, including four drugs for cancer subtypes that are identified by companion test kits.