Eisai Cancer Drug Gets Breakthrough Therapy Status
The US Food and Drug Administration (FDA) has granted breathrough therapy status for Eisai’s Lenvima (lenvatinib) for the potential indication of advanced and/or metastatic renal cell carcinoma. Lenvatinib is already approved in the United States, Japan, and Europe for treating refractory thyroid cancer.
The breakthrough therapy designation is intended to expedite development and review of drugs for serious or life-threatening conditions. The benefits of this designation include more intensive guidance on an efficient drug development program and submission strategy as well as eligibility for rolling review. Preliminary clinical evidence demonstrating the drug may have substantial improvement on at least one clinically significant endpoint over available therapy is required for breakthrough therapy designation.
Lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a 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) in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRÎ±; KIT; and RET) involved in tumor proliferation.
In addition to being study for renal cell carcinoma and approved for thyroid cancer, the drug is being studied in other cancer indications. Eisai is conducting a global Phase III study of lenvatinib in hepatocellular carcinoma as well as Phase II studies of lenvatinib in several other tumor types such as endometrial carcinoma and non-small cell lung cancer.