Lenvima Approved for RAI-Refractory Differentiated Thyroid Cancer

Lenvima Approved for RAI-Refractory Differentiated Thyroid Cancer
Lenvima Approved for RAI-Refractory Differentiated Thyroid Cancer

The Food and Drug Administration (FDA) has approved Lenvima (lenvatinib; Eisai) for the treatment of patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine (RAI) therapy.

Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other proangiogenic and oncogenic pathway-related tyrosine kinases thought to be involved in tumor proliferation.

RELATED: Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

The FDA approval was based on a study (n=392) that showed Lenvima was efficacious in patients with progressive, radioactive iodine-refractory differentiated thyroid cancer who were randomized to either Lenvima or placebo. Patients treated with Lenvima lived a median duration of 18.3 months (progression-free survival) vs. 3.6 months in patients treated with placebo. Also, a reduction in tumor size was seen in 65% of patients treated with Lenvima vs. 2% of patients treated with placebo.

For more information visit FDA.gov.