August 20, 2018

FDA Approves Lenvatinib for Treatment of Advanced Hepatocellular Cancer

By Anonymous User

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 (HCC). This approval was based on results from REFLECT, where LENVIMA demonstrated a proven treatment effect on overall survival as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.  The kinase inhibitor has previously been approved for differentiated thyroid cancer and renal cell cancer.

The safety and efficacy of lenvatinib in HCC are based on the randomized, open-label trial known as REFLECT, which used a noninferiority design involving sorafenib (Nexavar, Bayer), the treatment standard in this setting at the time of the trial, as the comparator.

The REFLECT trial assigned 954 treatment-naive patients with metastatic or unresectable HCC to lenvatinib at 8 mg or 12 mg once per day (n = 478) or sorafenib at 400 mg twice daily (n = 476).

Median overall survival was 13.6 months with lenvatinib compared with 12.3 months with sorafenib. Thus, the trial demonstrated that lenvatinib was noninferior to sorafenib for overall survival, which was the primary endpoint of the trial.

Median progression-free survival was 7.3 months in the lenvatinib group and 3.6 months in the sorafenib group.

The overall response rate was higher for the lenvatinib group than the sorafenib group (41% vs 12% per mRECIST and 19% vs 7% per RECIST 1.1).

The recommended lenvatinib dosages for patients with HCC are 12 mg orally once daily in patients with 60 kg or greater actual body weight or 8 mg orally once daily in patients with less than 60 kg actual body weight.


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