FDA Approves Nivolumab Dosing Update

On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved updated dosing information for nivolumab (Opdivo^®) (https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-now-first-and-only-fda-). Nivolumab is now the first FDA-approved PD-1 inhibitor that offers a flexible dosing option of every two weeks at 240 mg or every four weeks at 480 mg for most approved indications. The manufacturer, Bristol-Meyers Squibb, maintains a list of approved indications (https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-now-first-and-only-fda-). Nivolumab has also been approved for 30-minute infusions across all indications, reducing previous administration times by 50%.

Nivolumab has been approved (https://voice.ons.org/search/node?keys=nivolumab) for a number of indications to treat cancers, including hepatocellular carcinoma, colorectal cancers, advanced or metastatic bladder cancer, and more. Stay up to date on emerging FDA approvals (https://voice.ons.org/topic/us-food-and-drug-administration-fda) through ONS Voice.