Denileukin Diftitox Greenlighted for CTCL

The FDA approved denileukin diftitox (Lymphir; Citius Pharmaceuticals) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), which is characterized by debilitating skin lesions and extreme itching, after they’ve received at least one other systemic therapy. Denileukin diftitox targets IL2, which is found on malignant T cells and regulatory T cells. The approval was based on the phase III Pivotal Study 302, which assessed the drug’s effectiveness in 69 patients. The overall response rate was 36.2%, and the duration of response was at least 6 months for 52% of patients. Notably, 84.4% of patients saw their skin tumors decrease. Citius expects to begin selling the drug in about 5 months.