FDA Approves Opdivo (Nivolumab) for Liver Cancer

The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab), a monoclonal antibody, which is a type of immunotherapy, to treat liver cancer. It’s for people with hepatocellular cancer who were previously treated with Nexavar (sorafenib), a type of targeted therapy. Hepatocellular cancer is the most common type of liver cancer.

The FDA based its approval on a group of 154 people whose cancer got worse after taking Nexavar, or who were unable to tolerate Nexavar. After taking Opdivo, 3 people saw a complete response, which means they no longer had any evidence of cancer, and 19 people had a partial response, meaning their cancer shrank. Of the 22 people who saw a response, 91% had a response that lasted 6 months or longer and 55% had a response that lasted 12 months or longer.

Opdivo is given as an infusion into the vein every 2 weeks. It’s in a class of drugs called checkpoint inhibitors, which help your immune cells recognize and destroy cancer cells. Specifically, Opdivo blocks a protein on immune cells called PD-1. That protein actually helps cancer cells avoid detection. Blocking PD-1 means immune cells are better able to spot (and therefore attack) cancer.

The most common side effects of Opdivo are fatigue, rash, pain, itching, diarrhea, constipation, nausea, cough, shortness of breath, decreased appetite, infection, and fever.  In the study, there were more patients with hepatocellular carcinoma with very high increases in liver function tests than in studies where Opdivo was given to patients with other kinds of cancer.

Opdivo was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

The drug is marketed by Bristol-Myers Squibb.

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