Cutaneous T-Cell Lymphoma
FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
Published in Medical Letter on the CDC and FDA, July 13th, 2008
Eisai Corporation of North America announced 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...
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