Merck Receives FDA Approval for Keytruda in Adjuvant Urothelial Carcinoma

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) as adjuvant treatment for patients with high-risk urothelial carcinoma (UC) following radical resection. In the Phase 3 KEYNOTE-905/EV-303 trial, KEYTRUDA demonstrated a statistically significant improvement in disease-free survival compared to placebo. The 2-year DFS rate was 68.3% for KEYTRUDA versus 55.2% for placebo. This approval provides patients with high-risk resected UC a new adjuvant immunotherapy option to reduce the risk of cancer recurrence. Merck continues to study KEYTRUDA in earlier stages of urothelial carcinoma.