FDA Grants Lenvatinib Priority Review Designation for Advanced Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer and granted the application Priority Review status.
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.
Although treatment is possible for most types of thyroid cancer, once the disease has progressed to radioactive iodine–refractory differentiated thyroid cancer, treatment options are limited and there remains a significant unmet medical need.
The decision was based on the results of the phase III SELECT trial. This multicenter, randomized, double-blind, placebo-controlled study compared the progression-free survival of 392 patients with radioactive iodine–refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 12 months who were treated with once-daily oral lenvatinib or placebo.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
