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# FDA 2021 Personalized Medicine Milestones
- URL: https://www.fdaweb.com/fda-2021-personalized-medicine-milestones/
- Published: 2022-03-03T12:00:00.000Z
- Updated: 2026-09-14T17:34:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151286

A recent Personalized Medicine Coalition report lists six milestones for 2021 in terms of personalized medicine at FDA. The report says that despite the Covid-19 pandemic, the pace of progress in personalized medicine continues to accelerate as FDA more regularly and rapidly approves diagnostic tools and treatments that expand the field.

“With the approval of 17 new personalized medicines in 2021, personalized medicines now account for more than a quarter of the new drugs the agency has approved in the past seven years,” the report says. “This figure represents a sharp recent increase. Just a decade ago, personalized medicines accounted for less than 10% of the new therapies approved each year.”

The milestones cited in the report were: 

- approval of 17 personalized medicines, representing about 35% of all newly-approved therapeutic molecular entities;
- approval of two new chimeric antigen receptor (Car-T) cell-based immunotherapies;
- approval of a new therapy for adults with non-small-cell lung cancers whose tumors have a specific genetic mutation;
- recognition of a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base containing curated research and real-world information on specific alterations in 682 cancer-associated genes;
- clearance or approval of several significant new or expanded indications for nine *in vitro* diagnostic testing systems that can inform targeted therapeutic decisions; and
- approval of two personalized therapies to treat certain patient populations with familial hypercholesterolemia.