First-line approval granted by EC for Lenvima in liver cancer

Adding to a similar US approval last week, the European Commission (EC) has also granted a marketing authorization for the oral receptor tyrosine kinase (RTK) inhibitor Lenvima (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), or liver cancer, who have received no prior systemic therapy.

Lenvima was discovered by Japan’s Eisai (TYO: 4523) and is now commercialized in cooperation with US pharma giant Merck & Co (NYSE: MRK). News of the new approval had little stock market impact, with Eisai’s share up just a modest 0.16% at 9,675 yen.

This is the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately 10 years. Last week, the US Food and Drug Administration approved the kinase inhibitor Lenvima for the first-line treatment of patients with unresectable HCC.