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FDA grants priority review to lenvatinib for advanced thyroid cancer
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The FDA granted priority review status to lenvatinib mesylate as a treatment for patients with progressive radioactive iodine-refractory differentiated thyroid cancer, according to the drug’s manufacturer.
Lenvatinib (E7080, Eisai) is an oral multiple receptor tyrosine kinase inhibitor that inhibits VEGF receptors 1-3, fibroblast growth factor (FGF) receptors 1-4, platelet-derived growth factor (PDGF) receptor alpha, RET and KIT signaling networks.
The FDA based its decision in part on results from the phase 3 SELECT trial, in which 392 patients with radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 12 months were assigned 2:1 to daily 24 mg lenvatinib or placebo.
According to study results, patients assigned lenvatinib demonstrated significantly longer median PFS (18.3 months vs. 3.6 months; HR=0.21; 95% CI, 0.14-0.31).
Subgroup analyses indicated lenvatinib significantly extended median PFS among the 66 patients who had previously received VEGF-targeted therapy (15.1 months), as well as among the 195 patients who had not (18.7 months).
Four patients (1.5%) achieved a complete response with lenvatinib compared with no patients in the placebo arm. Researchers observed partial responses in 63.2% (n=165) of patients assigned lenvatinib and 1.5% (n=2) of patients assigned placebo.
Lenvatinib is currently under investigation as a treatment for patients with thyroid, hepatocellular, endometrial, non–small cell lung cancer and other solid tumor types.