The Personalized Medicine Coalition (PMC) today released a report documenting the U.S. Food and Drug Administration’s approval last year of 19 personalized therapies, one cell-based immunotherapy, and eight significant new diagnostic indications that will help physicians target treatments to only those patients who will benefit. Personalized medicines accounted for 39 percent of the new drugs FDA approved last year, topping one-third of new drug approvals for the third time in the last four years. The report underlines how FDA’s public policies are reinforcing the United States health care system’s shift toward a more effective and efficient era of personalized medicine even in the midst of a pandemic. It also demonstrates the biopharmaceutical and diagnostics industries’ continued commitment to the field.

Personalized Medicine at FDA: The Scope & Significance of Progress in 2020 describes how newly approved tests and therapies will help transform care for molecularly selected subsets of patients with cancer, rare diseases, and common/infectious diseases. Seven of the personalized therapies listed in the report are designed to address the root causes of devastating rare genetic diseases for which patients had few treatment options before. The report also notes how expanded indications will extend the unprecedented benefits of cancer immunotherapies to patients with solid tumors of all types that are tumor mutational burden-high (TMB-H). Perhaps most significantly, it explains how the first FDA-approved blood-based biomarker tests for cancer will help guide targeted treatment strategies for patients who are unable to undergo invasive operations to obtain tissue biopsies. The emergence of blood-based biomarker testing anticipates a new era in which cancers are detected at earlier stages, when they are easier and less expensive to treat.

“Personalized Medicine at FDA: The Scope & Significance of Progress in 2020 documents FDA’s unwavering commitment to expanding the frontiers of personalized medicine while also demonstrating industry’s commitment to developing innovative and groundbreaking products that serve patients and make health systems more efficient,” said PMC President Edward Abrahams.