Japanese pharma company Eisai can point to another accolade for its drug Lenvima/Kisplyx (lenvatinib) as it seeks regulatory approval of the drug in hepatocellular carcinoma (HCC).
The Lancet, one of the most influential medical journals, has published the results of a Phase III study comparing Lenvima with sorafenib, a standard treatment for advanced HCC.
In this study, Lenvima demonstrated a treatment effect on the primary endpoint of overall survival by statistical confirmation of non-inferiority to sorafenib. Additionally, it showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival, time to progression and objective response rate.
Eisai has submitted applications for Lenvima for the treatment of HCC in Japan, the USA, Europe, China, Taiwan and other markets. It has already obtained approval for its use in refractory thyroid cancer in more than 50 countries.
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