Lenvima Granted New Indication to Treat Liver Cancer
August 16, 2018 – The U.S. FDA has approved a new indication for Lenvima® (lenvatinib), manufactured by Eisai Inc. and Merck, as a first-line treatment for unresectable (inoperable) hepatocellular carcinoma (HCC). This is the first such approval granted by the FDA in more than 10 years.
The most common type of primary liver cancer, HCC can be difficult to treat and accounts for one third of cancer deaths worldwide. It occurs predominantly in individuals who have pre-existing liver conditions, such as scarring caused by hepatitis B and hepatitis C infection.
In a clinical study, patients on Lenvima achieved an overall survival time of 13.6 months compared to 12.3 months for patients treated with Beyer’s Nexavar® (sorafenib), with a median progression-free survival time of 7.3 months versus 3.6 months. In addition, the overall response rate with Lenvima was greater – 41% as opposed to just 12% with Nexavar. Recommended dosing under the new indication is based on the patient’s weight.
Lenvima received its initial FDA approval in 2015, and is also indicated to treat patients who have locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.