In August 2018, the FDA approved Lenvima (lenvatinib; from Eisai) as the first treatment for patients with unresectable hepatocellular carcinoma, or liver cancer. Lenvima was previously approved for thyroid cancer and for kidney cancer.
This new approval was based on a clinical trial of 954 patients with untreated metastatic or unresectable liver cancer, which showed that those who received Lenvima had on average double the time (7.3 months versus 3.6 months) without disease progression than those who received Nexavar (sorafenib). In addition, the response rate was 41% with Lenvima and 12% with Nexavar. The average overall survival was 13.6 months with Lenvima and 12.3 months with Nexavar.
The most common side effects with Lenvima in the study were similar to side effects reported in other studies.
