Nature reviews. Drug discovery
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In August 2011 vemurafenib (Zelboraf; Daiichi Sankyo/Roche), an inhibitor of BRAF kinase, was approved by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma with the BRAF(V600E) mutation.
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A recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan drug development.
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Nat Rev Drug Discov · Oct 2011
ReviewIntegrating predictive biomarkers and classifiers into oncology clinical development programmes.
The future of drug development in oncology lies in identifying subsets of patients who will benefit from particular therapies, using predictive biomarkers. These technologies offer hope of enhancing the value of cancer medicines and reducing the size, cost and failure rates of clinical trials. ⋯ Here, we present methods to adaptively integrate predictive biomarkers into clinical programmes in a data-driven manner, wherein these biomarkers are emphasized in exact proportion to the evidence supporting their clinical predictive value. The resulting programme demands value from predictive biomarkers and is designed to optimally harvest this value for oncology drug development.