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

23 August 2018

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK