The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.

The CHMP decision is based on outcomes from the Phase III CheckMate -9DW trial. Credit: National Cancer Institute on Unsplash.
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The decision is based on outcomes from the Phase III CheckMate -9DW trial.
According to the outcomes of the trial presented by the company in June last year, a statistically significant improvement in the primary endpoint of overall survival (OS) was observed.
The median OS of the trial was 23.7 months for the combination against 20.6 months observed with the investigator’s choice of lenvatinib or sorafenib.
The combination’s safety profile continued to be stable with earlier reported data, without new safety signals being detected.
In August last year, the supplemental biologics license application (sBLA) for the combination as a potential first-line treatment alternative for adult subjects with unresectable HCC was accepted by the US Food and Drug Administration (FDA).
A Prescription Drug User Fee Act (PDUFA) goal date of 21 April 2025 was assigned by the US regulator.
The combo also gained accelerated approval from the US regulator in 2020 based on outcomes from the Phase II CheckMate -040 trial.
A programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo is tailored to activate the body’s immune system, helping to restore its ability to fight tumours.
Bristol Myers Squibb Opdivo global programme lead and vice-president Dana Walker said: “The positive opinion received by the CHMP is a significant step forward in providing patients with additional treatment options, and we look forward to the upcoming European Commission review and the potential to expand the treatment landscape for adult patients with unresectable or advanced hepatocellular carcinoma.”