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FDA Approves Opdivo for Hepatocellular Carcinoma

Bristol-Myers Squibb news release; 2017 Sep 22

Publish date:: October 3, 2017

The FDA has granted accelerated approval to Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC).

Indications: Opdivo is a programmed death receptor-1 blocking antibody indicated for the treatment of patients with HCC who have been previously treated with sorafenib.

Dosage and administration: 240 mg every 2 weeks.

Efficacy and safety: Approval is based on results from a phase 1/2 open-label study showing that 14% of patients responded to treatment with Opdivo.

Side effects/risks: The most common adverse reactions are fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia.

Citation:

Bristol-Myers Squibb’s Opdivo (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with sorafenib [news release]. Princeton, NJ: Bristol-Myers Squibb Company. September 22, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/faslodex-receives-us-fda-approval-as-monotherapy-for-expanded-use-in-breast-cancer.html. Accessed October 1, 2017.

Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2017. https://packageinserts.bms.com/pi/pi_opdivo.pdf. Accessed October 1, 2017.

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