The US Food and Drug Administration has approved denileukin diftitox-cxdl (Lymphir, Citius Pharmaceuticals) for adults with relapsed or refractory stage 1-3 cutaneous T-cell lymphoma after prior systemic therapy. Citius acquired rights to market a reformulated product in 2021, targeting interleukin-2 receptors on malignant T cells. Approval was based on a study showing a 36.2% response rate, including complete responses in 8.7% of patients. Adverse events include capillary leak syndrome, visual impairment, and hepatotoxicity. The company plans to launch the drug within 5 months. This approval is significant for patients with cutaneous T-cell lymphoma, offering a new treatment option with the potential to rapidly reduce skin disease and control symptoms.
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FDA Approves Lymphir for R/R Cutaneous T-Cell Lymphoma
