The US FDA has granted approval to pembrolizumab for the adjuvant treatment of renal cell carcinoma (RCC) for those patients who have an intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and metastatic lesion resection.

The approval has come after the KEYNOTE-564 trial showed that adjuvant treatment with pembrolizumab after nephrectomy led to a significant improvement in disease-free survival (DFS). About 22% of patients receiving immunotherapy had events of recurrence or death compared to 30% of patients in the placebo group (HR 0.68, 95% CI 0.53-0.87, P=0.001). This was a multicenter, randomized, double-blind, placebo-controlled trial that included 994 patients with intermediate-high or high risk of RCC recurrence, or stage M1 with no disease evidence… (Medpage Today)