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news.Eisai Corporation of North America has announced that the FDA has accepted for priority review a supplemental biologics license application for Ontak.
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The supplemental biologics license application (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).
Eisai’s 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.