Japanese drugmaker Eisai’s US subsidiary has obtained breakthrough therapy status from the US Food and Drug Administration (FDA) for its anticancer agent Lenvima (lenvatinib mesylate) to treat advanced or metastatic renal cell carcinoma.
Lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, which 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 PDGFRa, KITm and RET, involved in tumour proliferation.
The designation was provided based on the results of a Phase II clinical trial (Study 205) of lenvatinib in advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy.
According to the firm, the trial results of the combination of lenvatinib plus everolimus showed a significant extension in progression-free survival (PFS), the study’s primary endpoint, compared with everolimus alone.
In addition, the study showed an extension in PFS compared with everolimus alone. Both the lenvatinib plus everolimus group and the lenvatinib alone group demonstrated an improvement in objective response rate compared with the everolimus alone group.
Lenvatinib received orphan drug status in the US, Japan and Europe to treat refractory thyroid cancer. It is also undergoing regulatory review in nine countries.
The company is carrying out global Phase III study of lenvatinib in hepatocellular carcinoma, as well as Phase II studies in several other tumour types such as endometrial carcinoma and non-small cell lung cancer.
Image: Metastatic renal cell carcinoma. Photo: courtesy of Yale Rosen.