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Boyiadzis, Michael M; Kirkwood, John M; Marshall, John L; Pritchard, Colin C; Azad, Nilofer S; Gulley, James L
Journal for immunotherapy of cancer, 05/2018, Volume: 6, Issue: 1Journal Article
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.
