The U.S. Food and Drug Administration (FDA) granted denileukin diftitox-cxdl approval for the treatment of relapsed or refractory (R/R) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
The treatment is a recombinant fusion protein that works by targeting the IL-2 receptor found on malignant T cells and regulatory T cells (Tregs). This is the medication’s first indication.
Approval was granted based on the results of an open-label, single-arm, multicenter, phase III trial evaluating the treatment in patients with R/R stage 1-4 CTCL. Results demonstrated an objective response rate of 36.2%, a complete response rate of 8.7%, and a median time to response of 14.1 months.
“We believe [denileukin diftitox-cxdl’s] unique IL-2 receptor-targeted treatment, which kills tumor cells directly and concurrently depletes host Tregs to boost the body’s immune response, is an important differentiator and offers clinically meaningful benefits to a significant percentage of R/R patients,” said Myron Czuczman, MD, chief medical officer of Citius Pharmaceuticals.
Common adverse reactions include decreased albumin, fatigue, musculoskeletal pain, capillary leak syndrome, pyrexia, edema, constipation, decreased hemoglobin, nausea, increased transaminases, chills, and rash.
Source: Citius Pharma, August 8, 2024.
