FDA approves pembrolizumab for MSI-high cancers (2017)
The US Food and Drug Administration approved pembrolizumab for any solid tumor with microsatellite instability-high or mismatch-repair-deficient features. It was the first approval tied to a genetic marker rather than tumor location.
Patients with these mutations gained a drug effective across multiple cancer types, not just one.
Established MMR deficiency as a predictive biomarker for immunotherapy, laying the foundation for trials like NEOPRISM-CRC.
The same genetic profile selected patients for this bowel cancer trial — the marker predicted who would respond to the drug.
