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.”