EMA approves KEYTRUDA® (pembrolizumab) as adjuvant treatment for Patients With Renal Cell Carcinoma

Pembrolizumab has been approved as a 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.

SPS commentary:

Approval was based on results from the KEYNOTE-564 trial, which 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) after a median follow-up of 23.9 months.

Biospace Inc.