Journal
JOURNAL FOR IMMUNOTHERAPY OF CANCER
Volume 6, Issue -, Pages -Publisher
BIOMED CENTRAL LTD
DOI: 10.1186/s40425-018-0342-x
Keywords
DNA mismatch repair; Microsatellite instability; Pembrolizumab; Biomarker; Immunotherapy
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Funding
- NATIONAL CANCER INSTITUTE [ZIABC010666] Funding Source: NIH RePORTER
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The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti-programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient's tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval.
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