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ABSTRACT: Importance
The number of new genome-targeted cancer drugs has increased, offering the possibility of personalized therapy, often at a very high cost.Objective
To assess the validity of molecular targets and therapeutic benefits of US Food and Drug Administration-approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.Design and settings
In this cohort study, all genome-targeted cancer drugs that were FDA-approved between January 1, 2015, and December 31, 2022, were analyzed. From FDA drug labels and trial reports, key characteristics of pivotal trials were extracted, including the outcomes assessed.Main outcomes and measures
The strength of evidence supporting molecular targetability was assessed using the E
SUBMITTER: Tibau A
PROVIDER: S-EPMC11099684 | biostudies-literature | 2024 May
REPOSITORIES: biostudies-literature