FDA approved Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved following a priority review.
Lenvima
demonstrated a statistically significant progression-free survival
prolongation and response rate in patients with progressive,
differentiated thyroid cancer who had become refractory to radioactive
iodine therapy.
In
the phase III SELECT trial, which included 392 patients, Lenvima
demonstrated a highly statistically significant improvement in PFS in
patients with RAI-R DTC compared with placebo. The median PFS with
Lenvima and placebo was 18.3 months and 3.6 months, respectively (HR
0.21; 95% CI: 0.16-0.28; p<0 .001="" span="">
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