FDA approves immunotherapy for patients with cutaneous T-cell lymphoma
The U.S. Food and Drug Administration has approved denileukin diftitox-cxdl for the treatment of adult patients with relapsed or refractory cutaneous T-cell lymphoma, according to a news release from OncLive.
The drug is a novel immunotherapy that targets the interleukin-2 receptor.
The FDA approval comes after positive results from the phase III Pivotal Study 302, in which 69 patients with stage I to III cutaneous T-cell lymphoma were assigned to receive a 9 μg/kg intravenous infusion of denileukin diftitox daily from days one to five on each 21-day cycle until disease progression or unacceptable toxicity.
The drug was found to have a favorable objective response rate, complete response rate, median time to response and duration of response. More than 84% of skin-evaluable patients achieved a reduction in skin tumor burden and over 12% of them had complete clearing of skin disease.
The FDA hopes denileukin diftitox can offer a new treatment option to patients with cutaneous T-cell lymphoma without inducing cumulative toxicity.
Read more: OncLive
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