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In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
In an FDAVoice blog posted July 11, 2017, FDA Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, MD, highlighted two recent drug approvals that she sees as encouraging for the future of “precision medicine”. Woodcock stated in the blog post that, in the past three years, CDER has approved more than 25 new drugs that target specific genetic characteristics, as well as new indications for drugs already available. In May 2017, FDA expanded approval of Kalydeco (ivacaftor) to 33 mutations of cystic fibrosis and Keytruda (pembrolizumab) to treat cancers with a specific genetic feature, rather than the location of the cancer in the body.
Development of biomarkers is key, according to Woodcock. Biomarkers are indicators, such as blood pressure, blood sugar, and tumor size, that can be measured. They can also be tests to identify genetic variants.
“Biomarkers can enable health care professionals and researchers to identify patients at risk of disease, determine the stage of a disease, and predict the likelihood that a patient will benefit from a drug. They also play a role in drug development,” Woodcock stated. “A particular biomarker, for example, can be used to identify appropriate candidates for a clinical trial, such as those patients likely to respond to treatment. This can make it easier and faster to recruit patients and may result in a shorter time for drug approval.”
Scientific understanding of how diseases work is important in identifying biomarkers, according to Woodcock. FDA has been encouraging drug developers to use biomarkers when developing treatments and is working with stakeholders and scientific consortia to qualify biomarkers.