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# Accelerated Approval Transforms Precision Oncology: Study
- URL: https://www.fdaweb.com/accelerated-approval-transforms-precision-oncology-study/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152890

Researchers from FDA and several academic medical centers say the accelerated approval process has been transformational in precision oncology and has particularly benefited patients with non-small cell lung cancer. Writing in *Nature Medicine*, the researchers [say](file:///C:/Users/edwar/Downloads/s41591-022-01984-z.pdf.docx) that since 1992 there have been 42 accelerated approvals in precision oncology for solid tumors.

Precision oncology is defined in the article as aiming to match the right drugs or treatments to the right patients, based on a genetic or molecular understanding of their disease.

“The opportunity to leverage accelerated approval has provided patients with cancer with early and broad access to potentially life-saving precision therapies,” the report says…. “A review of three decades of accelerated approvals in precision oncology for solid tumors suggests that this program has been highly successful.”

The researchers note that so far no accelerated approvals for precision oncology have been withdrawn. They also say the early clinical benefit predicted at the time of accelerated approval has been verified for 22 indications (52%), based on additional confirmatory studies.

“Innovative trial designs and nimble regulatory approaches are needed to keep pace with precision oncology’s scientific advances to provide broad and early access to life-saving drugs,” the authors conclude. “Just as precision oncology aims to match the right patients to the right drug, the accelerated approval pathway itself seems to be the right match for precision oncology.”