FDA Approves Lymphir (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

FDA approves Lymphir (denileukin diftitox-cxdl) immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Lymphir targets the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs, offering rapid skin relief without cumulative toxicity. The approval is based on a Phase 3 study showing a 36.2% Objective Response Rate (ORR) with 8.7% achieving Complete Response (CR), and a median time to response of 1.4 months.