The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a combination therapy consisting of ’s (BMS) Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with colorectal cancer. The recommendation is specifically for those with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). The gold standard of business intelligence.
The European Commission (EC) will review the CHMP’s recommendation before making a final decision on approval for the European Union (EU). The CHMP’s positive opinion is grounded in the outcomes from the Phase III, open-label CheckMate -8HW trial, which demonstrated a significant 79% decrease in disease progression or mortality risk compared to chemotherapy. The randomised trial evaluated the efficacy of Opdivo in combination with Yervoy against Opdivo alone or the investigator’s choice of chemotherapy.
839 patients were randomised to receive either Opdivo monotherapy, combination therapy or chemotherapy. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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