US FDA approves pembrolizumab for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer

Approval was based on RCT (n=307) that demonstrated a statistically significant improvement in progression-free survival (PFS) in the pembrolizumab vs. chemotherapy group; median PFS 16.5 months vs. 8.2 months, respectively. Potential for license extension in the UK is unknown.


US Food and Drug Administration