Bristol Myers (BMY) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer. Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% compared to chemotherapy in this patient population. The European Commission, which has the authority to approve medicines for the European Union, will now review the recommendation and make their decision.
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