Merck Receives FDA Approval for Keytruda in Early Triple-Negative Breast Cancer

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery, for adults with high-risk early-stage triple-negative breast cancer (TNBC). In the Phase 3 KEYNOTE-522 trial, the KEYTRUDA-based regimen demonstrated a statistically significant improvement in event-free survival compared to chemotherapy alone. The 5-year EFS rate was 81.3% for KEYTRUDA plus chemotherapy versus 72.3% for chemotherapy alone. This approval provides patients with high-risk early TNBC a new treatment option.