FDA Approves Lenvima for Treatment of Advanced Liver Cancer
by C.H. Weaver M.D. 8/18/2018
The U.S. Food and Drug Administration (FDA) approved the kinase inhibitor Lenvima® (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma. Lenvima has previously been approved for differentiated thyroid cancer and renal cell cancer. This approval in hepatocellular cancer was based on results from the REFLECT clinical trial.1
About Lenvima: Lenvima is an oral anti-angiogenic therapy that targets new blood vessel growth, lenvatinib can “starve” cancer of the nutrients it needs to grow.
About Hepatocellular Carcinoma (HCC)
The liver is the largest organ in the body and is responsible for over 500 functions, including the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and detoxification of numerous substances.
Liver cancer, or hepatocellular carcinoma (HCC), is the second most common cause of cancer-related deaths worldwide.2,3 The prognosis for patients with advanced liver cancer is poor,2 and the multikinase inhibitor, Nexaver, has been the only approved treatment, until the recent approval of Stirvaga.3
Factors that increase the risk of developing hepatocellular carcinoma include cirrhosis, long-term, heavy alcohol use, and chronic infection with hepatitis B or C viruses.4,5
The REFLECT clinical trial enrolled 954 treatment-naive patients with metastatic or unresectable hepatocellular carcinoma to receive treatment with either Lenvima once per day (n Nexavar twice daily and compared the outcomes.
Overall 41% of Lenvima treated patients responded to treatment compared to 12% for Nexavar. The average time to cancer progression nearly doubled to 7.3 months for Lenvima compared to 3.6 months for Nexavar. Overall survival however was 13.6 and 12.3 months for Lenvima and Nexavar respectively. The trial demonstrated that Lenvima was noninferior to Nexavar for overall survival, which was the primary endpoint of the trial.
Lenvima represents a new treatment option for individuals with advanced hepatocellular cancer. How best to use Lenvima will be further defined by ongoing clinical trials looking at its use in combination therapy and earlier in the disease course.
2018 Gastrointestinal Cancers Symposium. Abstract 207, presented January 19, 2018.
Gastrointestinal Cancers Symposium (GICS) 2018. Abstract 206, presented January 19, 2018.
Organization. Cancer. Available from: http://www.who.int/mediacentre/factsheets/fs297/en/. Last accessed: April 2017.
World Health Organization. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012. Available from: