articleNew England Journal of MedicineOct 11, 2017Closed access

First FDA Approval Agnostic of Cancer Site — When a Biomarker Defines the Indication

Center for Drug Evaluation and Research

PubMed
Indexed incrossrefpubmed

Abstract

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

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656
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43.32
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Authors

3

Topics & keywords

Keywords
  • Medicine
  • Pembrolizumab
  • Microsatellite instability
  • Food and drug administration
  • Cancer
  • Biomarker
  • Oncology
  • Internal medicine
UN Sustainable Development Goals
  • Good health and well-being
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