FDA Expands Nivolumab Approval for Type of Liver Cancer

09/25/17

The US Food and Drug Administration (FDA) has indicated nivolumab for intravenous use in patients with previously treated liver cancer.

Nivolumab (Opdivo, Bristol-Myers Squibb) is now approved for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. This indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval is contingent upon verification of clinical benefit in the confirmatory trials.

The CheckMate -040 trial has demonstrated that 14.35 (95% CI, 9.2-20.8) of patients with hepatocellular carcinoma responded to treatment with nivolumab.

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Adverse events associated with nivolumab include immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin reactions, and encephalitis.

“We are proud to bring the potential for clinically meaningful responses with immuno-oncology therapy to these advanced-stage hepatocellular carcinoma patients, who have had limited treatment options for years,” said Chris Boerner, president, US Commercial, Bristol-Myers Squibb, in a press release (September 24, 2017). “Today’s approval marks an important step toward our mission of delivering transformational medicines to treat conditions with a high unmet need.”—Zachary Bessette