Benzinga | Dec 17, 2021 09:54AM EST

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 (NYSE: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.