Recommendation Based on Significant Disease-Free Survival Benefit Demonstrated With KEYTRUDA Versus Placebo in Phase 3 KEYNOTE-564 Trial
San Francisco, CA (UroToday.com) — Merck, known as MSD outside the United States and Canada, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.