An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one third demonstrated substantial clinical benefits at the time of approval.The strength and quality of evidence supporting genome-targeted cancer drug approvals vary.
In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials. The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit and that qualified as ESCAT category level I-A or I-B .The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications.
Genomic Medicine Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Biologic Therapy Biologics Targeted Therapy Targeted Cancer Therapy Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study Single-Blind Studies Europe European U.S. Food And Drug Administration
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