EMA's CHMP Backs Approval For Merck's Keytruda In Adjuvant Setting For Kidney Cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval for Merck & Co Inc's  MRK Keytruda for renal cell carcinoma (RCC).

• The opinion covers Keytruda as monotherapy for the adjuvant treatment of RCC patients at increased risk of recurrence following nephrectomy or resection of metastatic lesions.
• The opinion is based on Phase 3 KEYNOTE-564 trial data, in which Keytruda reduced the risk of disease recurrence or death by 32% compared to placebo. 
• The European Commission will now review the CHMP's recommendation for marketing authorization in the European Union, and a final decision is expected in Q1 of 2022.
• Price Action: MRK shares are up 0.92% at $76.61 during the market session on the last check Friday.