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FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
Date:6/26/2008

REACTIONS:

Twenty-one percent (30/143) of patients required hospitalization for drug- related adverse events; the most common reasons were evaluation of fever, management of vascular leak syndrome or dehydration secondary to gastrointestinal toxicity.

The most commonly reported adverse reactions associated with the use of ONTAK therapy (n=143 patients) include hypoalbuminemia (83%), chills/fever (81%), asthenia (66%), nausea/vomiting (64%), transaminase increase (61%), infection (48%), pain (48%), edema (47%), hypotension (36%), anorexia (36%), and rash (34%).

Post-Marketing:

The following adverse reactions have been identified during post approval use of ONTAK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Special Senses: See WARNINGS: Visual Loss

For detailed safety information and full prescribing information about ONTAK (denileukin diftitox), please visit http://www.eisai.com.

About CTCL

Cutaneous T-cell lymphoma (CTCL) is a collective term for a group of rare malignant lymphomas. In patients with CTCL, certain cells that the body uses to fight infections, called T-cells, become cancerous and frequently result in skin lesions. CTCL is a slowly progressive disease for which there is no known cure. According to a recent study, CTCL affects approximately 1,900 people annually in the U.S. (6.4 cases per million people).

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.

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SOURCE Eisai Corporation of North America
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