WOODCLIFF LAKE, New Jersey—Eisai Corporation of North America has announced that FDA has accepted for priority review a supplemental biologics license application for the company's fusion toxin protein Ontak (denileukin diftitox).
The sBLA seeks to convert an accelerated approval indication into regular approval. It is based on a placebo-controlled phase III clinical trial conducted to confirm the clinical effectiveness of Ontak in certain cases of cutaneous T-cell lymphoma (CTCL).
Ontak was granted accelerated approval in February 1999 for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the interleukin-2 (IL-2) receptor.
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 IL-2 resulting in a molecule that is cytotoxic for cells bearing the target IL-2 receptor.