US FDA agrees to review Eisai’s application for Lenvima to treat HCC

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).

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.

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."