FDA granted a Breakthrough Therapy Designation to Lenvima (lenvatinib) in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor-targeted therapy.
Lenvima is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima is not indicated for patients with metastatic renal cell carcinoma.
Lenvima received the designation based on results of a phase II open-label, multicenter study involving 153 patients who were previously treated with a VEGF-targeted therapy and randomized 1:1:1 to receive Lenvima and everolimus (18+5 mg once a day), Lenvima (24 mg once a day) or everolimus (10 mg once a day).
Nearly all patients (99 percent) had received one prior VEGF-targeted therapy, 1 percent had received two prior VEGF-targeted therapies, and 18 percent had received prior immunotherapy treatment. The results of this study were presented in an oral presentation at the 2015 annual meeting of the American Society of Clinical Oncology.
Lenvima, sponsored by Eisai, inhibits the kinase activities of vascular endothelial growth factor receptors VEGFR1-3. Lenvima 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 receptors FGFR1-4; the platelet derived growth factor receptor alpha, KIT, and RET.
Lenvima was approved under the Priority Review designation for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer by the FDA in February 2015.