Lenvatinib Submitted to FDA for Thyroid Cancer Approval

the Cancer Therapy Advisor take:

Eisai has filed a new drug application with the U.S. Food and Drug Administration (FDA) for lenvatinib for the treatment of patients with progressive radioiodine-refractory, differentiated thyroid cancer. Lenvatinib was granted orphan drug status by the FDA in February 2013.

The new drug application filing is based on the phase 3 double-blind, randomized, placebo-controlled SELECT study, which showed that lenvatinib delayed disease progression by 18.3 months compared with 3.6 months in the placebo group. In addition, 65% of patients taking lenvatinib experienced partial responses and 2% attained a complete response.

The study also found that lenvatinib caused several adverse effects, including hypertension, diarrhea, fatigue, decreased appetite, nausea, and vomiting.

Lenvatinib is a tyrosine kinase inhibitor that targets VEGFR1-3, FGFR1-4, PDGFR-β, KIT, and RET. If approved, lenvatinib would most likely be administered orally once daily as a 24 mg dose to patients whose differentiated thyroid cancer is 131I-refractory or -resistant following external beam radiotherapy or radiofrequency ablation.

Another targeted tyrosine kinase inhibitor, sorafenib, was approved by the FDA in November 2013 for radioiodine-resistant differentiated thyroid cancer.