In a report released this morning, the Personalized Medicine Coalition (PMC) explains how 12 personalized treatments and seven diagnostics the U.S. Food and Drug Administration (FDA) approved or cleared in 2019 will improve patient care and make the health system more efficient by addressing root causes of rare diseases, expanding treatment options for cancer patients, and targeting therapies to responder populations. The approvals and clearance decisions expand the frontiers of the rapidly evolving field of personalized medicine for the benefit of patients and health systems.

Personalized Medicine at FDA: The Scope & Significance of Progress in 2019 defines personalized medicine as a field “in which physicians use diagnostic tests to determine which medical treatments will work best for each patient or use medical interventions to alter molecular mechanisms, often genetic, that cause disease or influence a patient’s response to certain treatments.” The report classifies 11 new therapeutic molecular entities and one gene therapy as personalized treatments. Five of those treatments are the first to address root causes of devastating rare diseases. Four others provide new options for cancer patients, and two include FDA labeling that will help patients avoid debilitating and costly adverse side effects. The report also explains how seven newly cleared or approved diagnostics will help make the health care system more efficient by targeting treatments to only those patients who will benefit from them, sparing expenses and side effects for those who will not.

“Personalized Medicine at FDA: The Scope & Significance of Progress in 2019 reminds us that personalized medicine offers new hope to patients with devastating diseases as well as opportunities to avoid prescribing therapies that will be unsafe or ineffective for certain populations of patients,” said Edward Abrahams, President, PMC.

In classifying 11 of the 44 (25 percent) new therapeutic molecular entities FDA approved last year as personalized medicines, this year’s report marks the sixth straight year that personalized medicines have accounted for more than 20 percent of the agency’s new drug approvals. These approvals have increased sharply since 2005, when personalized medicines accounted for just 5 percent of newly approved therapies.