The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Keytruda is sponsored by Merck.
The positive opinion is based on results from the pivotal phase III 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, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high-risk following nephrectomy and those with resected advanced disease).
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2022.
