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Citius Pharmaceuticals, Inc. and Citius Oncology, Inc. Announce LYMPHIR™ (Denileukin Diftitox-cxdl) Added to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
CRANFORD, N.J., Sept. 5, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and Citius Oncology, Inc.
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CRANFORD, N.J., Sept. 5, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius Pharma\" or the \"Company\") (Nasdaq: CTXR) and Citius Oncology, Inc. (\"Citius Oncology\") (Nasdaq: CTOR), today announced that LYMPHIR™ has been added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). LYMPHIR is included based on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that the drug is appropriate as an option for patients with Cutaneous T-cell Lymphoma (CTCL). \n\n \n \n \n \n \n \n\n \nLYMPHIR (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory CTCL after at least one prior systemic therapy, was recently approved by the U.S Food and Drug Administration (FDA). The approval of LYMPHIR is based on results from the Phase 3 Pivotal Study 302 (NCT01871727) of CTCL patients who had previously received at least one systemic treatment. LYMPHIR is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs.\n\"The inclusion of LYMPHIR in the NCCN Guidelines is a testament to the clinical evidence supporting this therapy, and further supports healthcare professionals in considering LYMPHIR as part of the recommended treatment protocols for CTCL. We are grateful to the NCCN board for its recognition of LYMPHIR, paving the way for expanded access to this important treatment option,\" stated Leonard Mazur, CEO of Citius Pharma and Citius Oncology.\n\"NCCN guidelines are widely regarded as the gold standard for clinical decision-making in oncology and hematology, influencing treatment practices and payor reimbursement in the U.S. We believe that LYMPHIR has the potential to improve CTCL patient outcomes, and expect its addition to the NCCN Guidelines may aid adoption and ease reimbursement, particularly for the anticipated patients that qualify for Center for Medicare and Medicaid (CMS) coverage,\" added Mazur.\nAbout LYMPHIR™ (denileukin diftitox-cxdl)\nLYMPHIR is a targeted immune therapy for r/r (R/R) CTCL indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that h...