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Citius Pharmaceuticals Receives FDA Approval for LYMPHIR™ (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Only systemic treatment for relapsed or refractory (r/r) CTCL to target the IL-2 receptor on malignant T-cells and TregsLYMPHIR is expected to launch within
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Only systemic treatment for relapsed or refractory (r/r) CTCL to target the IL-2 receptor on malignant T-cells and TregsLYMPHIR is expected to launch within the next five monthsLYMPHIR's approval marks the first novel targeted systemic therapy approved by the FDA r/r CTCL since 2018Approval based on Phase 3 Pivotal Study 302 results that demonstrated 36% ORR, reduction in skin disease in 84% of patients, clinically significant pruritis improvement, and no cumulative toxicityCRANFORD, N.J., Aug. 8, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) (\"Citius\", \"Citius Pharma\"), announced today that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This is the first indication for LYMPHIR and the first FDA-approved product for Citius Pharma.\n\n \n \n \n \n \n \n\n \n\"LYMPHIR offers new hope for patients suffering from cutaneous T-cell lymphoma, a rare and chronic cancer characterized by debilitating skin lesions and severe itching. This approval is a significant milestone for CTCL patients. The introduction of LYMPHIR, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the CTCL treatment landscape and grow the overall market, currently estimated to be $300-$400 million,\" stated Leonard Mazur, Chief Executive Officer of Citius Pharmaceuticals.\n\"LYMPHIR, with an initial indication in the treatment of CTCL, is the first of our pipeline candidates to receive FDA approval. Citius is dedicated to working closely with healthcare providers to ensure that all r/r CTCL patients have timely access to this important new therapy. We are preparing to launch LYMPHIR in the U.S. market within the next five months,\" added Mazur.\n\"We are grateful to the clinicians, patients, and researchers who contributed to the development of LYMPHIR. We believe LYMPHIR's unique IL-2 receptor-targeted treatment, which kills tumor cells directly, and concurrently depletes host Tregs in order to boost the body's immune response, is an important differentiator and offers clinically...