Abstract
Oncology drugs target discrete molecular aberrations or pathways in tumor cells; due to the intrinsic heterogeneity of tumors, many drugs are only active in a subset of patients. Predictive biomarkers, measured using in vitro companion diagnostics (IVD), help identify patients likely to respond to treatment and are increasingly integrated into drug development programs. This presentation will provide an update of biomarker-assisted oncology drugs approved by the US FDA. Case studies will be presented on therapeutic monoclonal antibodies selectively targeting HER2, EGFR, or PD-1/PD-L1 signaling pathways. This information will be further discussed with respect to biomarker discovery in the development of novel cancer therapeutics.
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