Merck gets positive EU CHMP opinion for Keytruda as adjuvant therapy in RCC following surgery
Kenilworth: Merck known as MSD outside the United States and Canada, has 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.
The positive opinion is based on results 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, 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).
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