Posted by Michael Wonder on 20 Nov 2021
FDA approves Merck’s Keytruda (pembrolizumab) as adjuvant therapy for certain patients with renal cell carcinoma following surgery
18 November 2021 - Keytruda is the first immunotherapy approved for the adjuvant treatment of these patients with renal cell carcinoma.
Merck today announced that the U.S. FDA has approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which Keytruda demonstrated a statistically significant improvement in disease-free survival, reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo.
