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Opdivo Approved for Hepatocellular Carcinoma

Bristol-Myers Squibb news release; 2017 Sep 22

The FDA has approved Opdivo (nivolumab) for the treatment of hepatocellular carcinoma in patients who have already been treated with sorafenib.

Indications: Opdivo is indicated for liver cancer in patients who previously received sorafenib and was approved under an accelerated approval process that took into account tumor response rate and durability of patients’ response. The FDA stipulates that continued approval may depend on verification of clinical benefits in follow-up trials.

Dosage and administration: 240 mg every 2 weeks as an IV infusion over 60 minutes.

Adverse reactions: OPDIVO as a single agent can cause fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia. The drug also has a warning attached to it that includes the risk of immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, and encephalitis.

Citation:

Bristol-Myers Squibb’s Opdivo (nivolumab) receives FDA approval for the treatment of hepatocellular carcinoma patients previously treated with sorafenib. September 22, 2017. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-receives-fda-approval-t. Accessed Sep 26, 2017. https://packageinserts.bms.com/pi/pi_opdivo.pdf.