Eisai Corporation of North America has announced that the FDA has approved an efficacy supplemental biologics license application for Ontak solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin receptor.
A separate efficacy supplement that included data from patients with cutaneous T-cell lymphoma (CTCL) whose malignant cells did not test positive for the CD25 component of the IL-2 receptor received a complete response letter.
The FDA’s action, following a priority review, marks the conversion of an accelerated approval indication to full approval and is based on data from a Phase III clinical trial that evaluated the overall efficacy and safety of Ontak in certain patients with CTCL.
Hajime Shimizu, chairman and CEO of Eisai, said: “The full approval of Ontak is in keeping with our human health care mission, to address the unmet medical needs of patients with CTCL. As an orphan drug indicated for a rare disease, Ontak has the potential to make a difference for this patient population.”