Merck Receives FDA Approval for Keytruda in Resectable Non-Small Cell Lung Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery, for adults with resectable non-small cell lung cancer (NSCLC). In the Phase 3 KEYNOTE-671 trial, the KEYTRUDA-based perioperative regimen demonstrated a statistically significant improvement in event-free survival and overall survival compared to chemotherapy alone. The 2-year EFS rate was 62.4% for KEYTRUDA versus 40.6% for chemotherapy. This approval provides patients with resectable NSCLC a new perioperative treatment option.