First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.
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Summary
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.
- Type
- article
- Published
- 2017-10-11
- Cited by
- 551
- References
- 5
- OpenAlex
- https://openalex.org/W2763584377
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:5480723
Keywords
Medicine, Pembrolizumab, Microsatellite instability, Food and drug administration, Cancer
References
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- Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: a pooled analysis of the CAIRO, CAIRO2, COIN and FOCUS studies
- Microsatellite Instability as a Biomarker for PD-1 Blockade
- Classification and characterization of microsatellite instability across 18 cancer types
- Abstract PD2-08: Neratinib + fulvestrant inERBB2-mutant, HER2–non-amplified, estrogen receptor (ER)-positive, metastatic breast cancer (MBC): Preliminary analysis from the phase II SUMMIT trial
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