Lenvatinib Granted Breakthrough Therapy for Advanced or Metastatic Renal Cell Carcinoma
Eisai announced that the Food and Drug Administration (FDA) granted lenvatinib Breakthrough Therapy designation for use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
The Breakthrough Therapy designation for lenvatinib was based on results of a Phase 2 open-label, multicenter study involving 153 patients who were previously treated with a VEGF-targeted therapy and randomized 1:1:1 to receive lenvatinib and everolimus (18+5mg once a day), lenvatinib (24mg once a day) or everolimus (10mg once a day). Nearly all patients (99%) had received one prior VEGF-targeted therapy, 1% had received two prior VEGF-targeted therapies, and 18% had received prior immunotherapy treatment.
Lenvatinib, marketed under the brand name Lenvima, is approved for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). It is not indicated for patients with metastatic renal cell carcinoma. Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1-3. It also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
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