First FDA approval agnostic of cancer site — when a biomarker defines the indication

New England Journal of Medicine

11 October 2017 - In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and paediatric patients with unresectable or metastatic, microsatellite-instability–high or mismatch-repair–deficient solid tumours, regardless of tumour site or histology.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Regulation , Biomarker