FDA Accepts for Priority Review Application for Nivolumab in Previously Treated Hepatocellular Carcinoma

Application is based on results from the phase I/II CheckMate -040 trial

On 24 May 2017, Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of nivolumab (Opdivo) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted nivolumab orphan-drug designation for the treatment of HCC.

 The FDA action date is 24 September, 2017.

The submission was based on data from the phase I/II CheckMate -040 study investigating nivolumab in advanced HCC patients with and without hepatitis B virus (HBV) or hepatitis C virus (HCV) infections. Data from this study were recently published in The Lancet and will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 during a poster discussion session on 3 June.

HCC is the most common type of liver cancer and the second most frequent cause of cancer death worldwide. More than 700,000 people around the world, including about 40,000 people in the United States, are diagnosed with HCC each year. The majority of these cases are caused by HBV or HCV infections, making HBV/HCV the most common risk factors for liver cancer.

HCC is often diagnosed in the advanced stage where treatment options are limited and outcomes are poor, with one-year survival rates in the advanced setting of approximately 44%. For patients who are intolerant to or who have progressed during sorafenib therapy, median survival remains less than 11 months with currently available treatment options.

The press release from Bristol-Myers Squibb contains "forward-looking statements".