20 Precision Meds Approved by FDA in 2020

(Arek Socha, Pixabay)

12 Feb. 2021. A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020. The report by the Personalized Medicine Coalition in Washington, D.C. says precision medicines account for a quarter or more of all new drugs approved by FDA each year in the past six years.

Precision or personalized medicines are prescribed by physicians to meet a patient’s molecular make-up, based on results of diagnostics, and the individual’s medical history. The 20 drugs and biologics approved by FDA in 2020 include 19 new drugs that target or require specific biomarkers, or biologic indicators, for various types of cancer, rare inherited diseases, neurological disorders, pain, and HIV. The agency also approved an immunotherapy for mantle cell lymphoma directed by genetically engineered T-cells, altered to express chimeric antigen receptors, known as CAR T-cells.

The 20 new approvals in 2020 account for 39 percent of all new drugs and biologics okayed by FDA in 2020. Since 2015, at least a quarter of FDA’s new drug approvals each year are precision medicines.

The report says FDA cleared eight new diagnostics in 2020 designed to support precision medicines. The new diagnostics include tests for solid tumors that identify specific biomarkers, independent of tissue or organs where the tumors reside. FDA also cleared a liquid biopsy, a blood test to detect cancer, that identifies cell-free DNA as indicators of cancer, instead of invasive tissue biopsies requiring surgery.

New regulatory guidance documents

In addition, FDA issued seven guidance documents in 2020 related to precision medicine. The guidance provided to developers include the agency’s thinking on manufacturing and control of gene therapies, long-term follow-up after administration of gene therapies, interpreting gene therapies under orphan drug regulations, and testing viral vector-based gene therapies during manufacturing and patient follow-up.

As reported by Science & Enterprise in January 2020, FDA also published a set of guidance documents for three types of disorders: hemophilia, rare diseases, and retinal disorders. Those documents were issued in draft by FDA in July 2018. Looking ahead, in January 2021, FDA issued draft administrative and procedural guidelines for genetic disorders treated with precise gene therapies.

Edward Abrahams, president of Personalized Medicine Coalition, says in an organization statement that the report, “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.”

More from Science & Enterprise:

• FDA Issues Precision Genomic Drug Guidance
• FDA Begins Qualifying Non-Animal Testing Options
• FDA Issues Guidance to Boost Clinical Trial Diversity
• FDA Bucks White House, Issues Strict Vaccine Guidance
• FDA Sets Review Criteria for Covid-19 Vaccines

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