Image: Hepatocellular carcinoma. Photo: courtesy of Ed Uthman via Wikipedia.

 

The US Food and Drug Administration (FDA) has agreed to review Eisai’s application for an additional indication of Lenvima (lenvatinib mesylate) as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Commonly referred to as liver cancer, HCC is currently the second leading cause of cancer-related death.

Discovered and developed in-house, Lenvima is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a new binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4).

It also inhibits other proangiogenic and oncogenic pathway-related RTKs, including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET involved in tumour proliferation.

The FDA has designated lenvatinib as an orphan drug used to treat patients with HCC.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“Patients with advanced liver cancer face a debilitating, life-threatening disease and additional treatment options are needed for these patients.”

The application for Lenvima is based on the results of a multicentre, open-label, randomised, global Phase III Reflect trial that studied the efficacy and safety of the Eisai therapy against sorafenib, a standard treatment for HCC.

During the trial, the drug demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority to sorafenib.

Eisai Oncology Business Group chief scientific officer Dr Kenichi Nomoto said: “Patients with advanced liver cancer face a debilitating, life-threatening disease and additional treatment options are needed for these patients.

“Given the importance of the Reflect study results, in which lenvatinib was the first first-line systemic therapy to demonstrate positive results when compared to sorafenib in a Phase III trial in patients with HCC in more than a decade, we will work closely with the FDA in hopes of bringing a new treatment option to patients living with advanced liver cancer.”