Skip to Main Content

Nivolumab Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

At The Dignity Health – Cancer Institute at St. Joseph’s Hospital and Medical Center our multidisciplinary team combines expertise from two Dignity Health centers of excellence - the Dignity Health – Cancer Institute at St. Joseph’s and The Center for Liver Disease and Transplantation - to to form a multidisciplinary team of specialists focused on the treatment of liver cancer. The team ensures the timely assessment of patients and an in depth discussion during our Liver Cancer tumor board where pathology, imaging and current national guidelines are reviewed to determine a customized treatment plan for each patient. For more information, please call (855) 484-7046.

Below is a brief summary about Nivolumab.

Nivolumab (brand name Opdivo®) is the first and only Immuno-Oncology agent to receive this FDA approval; this accelerated approval is based on tumor response rate and durability of response in these patients.

The burden of liver cancer in the U.S. is significant and is expected to increase in the decades to come.3,4 A recently-released American Cancer Society (ACS) report published in CA: A Cancer Journal for Clinicians notes that death rates for liver cancer are increasing at a faster pace than any other cancer, doubling since the mid-1980s.3

Hepatocellular carcinoma is often diagnosed in the advanced-stage where treatment options are limited and there is a high unmet need for patients who are intolerant to or who have progressed on sorafenib therapy.3,5,6

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer and the fastest-growing cause of cancer death in the U.S.1,3,7 The incidence of liver cancer in the U.S. has more than tripled since 1980.3 It is estimated that there will be approximately 41,000 new cases of liver and intrahepatic bile duct cancer and 29,000 deaths from these diseases in the U.S. this year.2 The majority of these cases are caused by Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infections, making chronic infection with HBV or HCV the most common risk factor for liver cancer.7,8 However, the increasing prevalence of metabolic syndrome and nonalcoholic steatohepatitis (NASH) is expected to contribute to increased rates of HCC in the U.S. in the foreseeable future.9,10


OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

Nivolumab injection may cause side effects and some may be serious. Ask your physician to explain these in detail during your visit. 


  1. American Cancer Society. Cancer Facts & Figures. 2017. Atlanta: American Cancer Society; 2017.
  2. National Cancer Institute. Surveillance, Epidemiology, and End Results Program Stat Fact Sheets: Liver and Intrahepatic Bile Duct Cancer. Accessed July 31, 2017.
  3. Islami F, Miller K, Siegel R, et al. Disparities in Liver Cancer Occurrence in the United States by Race/Ethnicity and State. Ca Cancer J Clin 2017 Jul 8;67(4):273–289.
  4. Wang S, Sun H, Xie Z, et al. Improved survival of patients with hepatocellular carcinoma and disparities by age, race, and socioeconomic status by decade, 1983-2012. Oncotarget. 2016 Sep 13;7(37):59820-59833.
  5. Allaire M and Nault JC. Advances in management of hepatocellular carcinoma. Curr Opin Oncol. 2017 Jul;29(4):288-295.
  6. Mlynarsky L, Menachem Y and Shibolet O. Treatment of hepatocellular carcinoma: Steps forward but still a long way to go. World J Hepatol. 2015 Mar 27;7(3):566-74.
  7. Mittal S and El-Serag HB. Epidemiology of hepatocellular carcinoma: consider the population. J Clin Gastroenterol. 2013 Jul; 47 Suppl:S2-6.
  8. American Cancer Society. Liver Cancer Risk Factors. Accessed August 8, 2017.
  9. Dhanasekaran R, Limaye A and Cabrera R. Hepatocellular carcinoma: current trends in worldwide epidemiology, risk factors, diagnosis, and therapeutics. Hepat Med. 2012 May 8;4:19-37.
  10. Yang JD and Roberts LR. Hepatocellular carcinoma: a global view. Nat Rev Gastroenterol Hepatol. 2010 Aug; 7(8):448-58.