Bristol-Myers Squibb (BMY) said Friday that a European Medicines Agency committee has recommended the approval of Opdivo in combination with Yervoy for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.
Results from the CheckMate -8HW study demonstrated a reduction in risk of disease progression or death by 79% relative to chemotherapy in the patient population, the company said.
The recommendation by the Committee for Medicinal Products for Human Use will now be reviewed by the European Commission before a final decision is made, Bristol-Myers added.
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