Also known as: LYMPHIR
Denileukin diftitox-cxdl is an IL-2 receptor-targeted immunotherapy marketed as Lymphir for relapsed or refractory cutaneous T-cell lymphoma after prior systemic treatment. It is described as a targeted systemic CTCL therapy and was approved by FDA in August 2024. The treatment is used in adults and has additional postmarketing safety requirements.
A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
The global oncology market is projected to grow from $280 billion in 2026 to $748 billion by 2035 at 11.54% CAGR, driven by rising cancer incidence, precision medicine expansion, and strong immunotherapy pipelines across multiple tumor types.
