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Therapeutic efficacy of Lenvatinib

1 Differentiated Thyroid Cancer

A multicenter, randomized (2:1), double-blind, placebo-controlled study (SELECT;  NCT01321554) was conducted in 392 patients with locally recurrent or metastatic  radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of  disease progression within 12 months prior to randomization, confirmed by independent  radiologic review. 

A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated  patients compared to those receiving placebo (Table 14 and Figure 1). Upon confirmation of  progression, 83% of patients that were randomly assigned to placebo crossed over to receive  open-label lenvatinib.

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from FDA,2024.06

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