New Indication for Opdivo
September 22, 2017 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab) injection for intravenous (IV) use, manufactured by Bristol-Myers Squibb. The drug is now approved as a second-line treatment for patients who have hepatocellular carcinoma (HCC), and who have been previously treated with Nexavar® (sorafenib).
HCC is associated with chronic liver diseases, including hepatitis and non-alcoholic steatohepatitis (NASH), and is the most common form of liver cancer. In the majority of cases, HCC occurs when there has been long-term damage and scarring of the liver (cirrhosis), though patients diagnosed with Hepatitis B or C are at high risk regardless of whether they develop cirrhosis. The prognosis for patients diagnosed with HCC is typically poor if complete surgical removal of cancerous tumors is not possible. An estimated 29,000 patients in the U.S. are expected to die of the disease in 2017.
A PD-1 inhibitor that aids the immune system in identifying and attacking cancer cells, Opdivo holds a number of previous indications for treatment of various forms of cancer. Recommended dosing for the treatment of HCC is a 240mg by intravenous infusion once every two weeks.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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