FDA Grants Orphan Drug Designation for Lenvatinib

Eisai announced that the FDA has granted Orphan Drug Designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer. Lenvatinib is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

Thyroid cancer more commonly occurs in women than in men, usually between the ages of 25 and 65. The most common types of thyroid cancer, papillary and follicular, including Hurthle cell, are classified as differentiated thyroid cancer (DTC) and account for approximately 95% of all cases.  While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer.

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