The agent, which has returned to the US market in a reformulated version, is indicated for adults with relapsed or refractory stage 1-3 disease.
The US Food and Drug Administration has approved denileukin diftitox-cxdl for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after at least one prior systemic therapy.), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. CitiusThis is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.
Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 through day 5 of 21-day cycles until disease progression or unacceptable toxicity.
Cutaneous T-Cell Lymphoma (CTCL) Non-Hodgkin's Lymphoma Non-Hodgkin Lymphoma NHL Skin Cancer Malignant Skin Neoplasm Lymphoma Malignant Lymphoma Toxicology Toxicity Poisoning Toxins Refractory Biologic Therapy Biologics Visual Impairment Vision Impairment Capillaries Impairment Pruritus Pruritis Itch Vision Care And Maintenance Interleukin-2 Il-2
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