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FDA Grants Orphan Drug Status To Eisai's Lenvatinib
Date:2/14/2013

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

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The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs 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 percent 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.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission,
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SOURCE Eisai Inc.
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