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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

sBLA Submission Based on Data from Placebo-Controlled Phase III Trial;

Largest Enrollment of CTCL Patients in a Randomized Study

WOODCLIFF LAKE, N.J., June 26 /PRNewswire/ -- Eisai Corporation of North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for ONTAK(R). The sBLA seeks to convert an accelerated approval indication into full approval. It is based on a placebo-controlled Phase III clinical trial to confirm the clinical effectiveness of ONTAK in certain patients with cutaneous T-cell lymphoma (CTCL).

ONTAK is indicated for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the IL-2 receptor. 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. ONTAK was granted accelerated approval under Subpart E in February 1999.

CTCL is a rare form of cancer in which T-cells, cells that the body uses to fight infections, become cancerous and affect the skin. CTCL can also spread to other organs in a small number of patients.

Subpart E is an FDA regulation that allows the accelerated approval of a biologic agent based on a surrogate endpoint or an effect on a clinical endpoint other than survival and is most common in serious diseases or for medications that fill an unmet medical need. All Subpart E approvals are contingent on the completion of post-marketing clinical trials that confirm a clinical benefit of the biologic agent.

About ONTAK

ONTAK is a genetically engineered fusion toxin protein consisting of the amino acid sequences for the enzymatically-active portion of diphtheria toxin fused to the sequence of human interleukin-2, resulting in a molecule that is cytotoxic for cells bearing the target IL-2 receptor.

ONTAK is indicated for
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SOURCE Eisai Corporation of North America
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