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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

the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the IL-2 receptor (see PRECAUTIONS, Laboratory Tests, in full prescribing information for CD25 expression testing). The safety and efficacy of ONTAK in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined.

IMPORTANT SAFETY INFORMATION

WARNING: Only physicians experienced in the use of antineoplastic therapy and management of patients with cancer should use ONTAK (denileukin diftitox). Patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation and where the patient can be closely monitored for an appropriate period based on his or her health status.

CONTRAINDICATIONS:

ONTAK is contraindicated for use in patients with a known sensitivity to denileukin diftitox or any of its components: diphtheria toxin, IL-2, or excipients.

WARNINGS:

Acute Hypersensitivity-type Reactions

-- Acute hypersensitivity reactions were reported in 98 of 143 patients (69%) during or within 24 hours of ONTAK infusion; approximately half of the events occurred on the first day of dosing regardless of the treatment cycle.

-- The constellation of symptoms included one or more of the following, defined as the incidence (%) in these 98 patients: hypotension (50%), back pain (30%), dyspnea (28%), vasodilation (28%), rash (25%), chest pain or tightness (24%), tachycardia (12%), dysphagia or laryngismus (5%), syncope (3%), allergic reaction (1%), or anaphylaxis (1%). These events were severe in 2% of patients.
-- Death during infusion has been reported.

Vascular Leak Syndrome

-- This syndrome, characterized by 2 or more of the following 3 symptoms was reported in 27% (38/143) of patients in the clinical studies: hypotension, edema, hypoalbuminemia.

-- Six percent (8/143) of
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SOURCE Eisai Corporation of North America
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