Merck Receives FDA Approval for Keytruda in Adjuvant Hepatocellular Carcinoma

Merck today announced that the FDA has approved KEYTRUDA (pembrolizumab) as adjuvant treatment for adults with hepatocellular carcinoma (HCC) who have undergone surgical resection or local ablation and have complete radiological response. In the Phase 3 KEYNOTE-937 trial, KEYTRUDA demonstrated a statistically significant improvement in recurrence-free survival compared to placebo. The median RFS was not reached for KEYTRUDA versus 22.1 months for placebo. This approval provides patients with resected or ablated HCC a new adjuvant immunotherapy option to reduce the risk of cancer recurrence.