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Citius Oncology Announces U.S. Commercial Launch of LYMPHIR™, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL)
LYMPHIR now available nationwideCRANFORD, N.J., Dec. 1, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"LYMPHIR now available nationwideCRANFORD, N.J., Dec. 1, 2025 /PRNewswire/ -- Citius Oncology, Inc. (\"Citius Oncology\") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (\"Citius Pharma\") (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.\n \n \n \n \n \n \n \n\"LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology. With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease,\" said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. \"This is our first marketed product and the culmination of years of development work and commercial preparation. LYMPHIR addresses a clear clinical need in a disease with limited treatment options. Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future. Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it,\" added Mazur.The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients. Median time to response was 1.4 months. Importantly, LYMPHIR was not associated with cumulative toxicity.\"LYMPHIR is an important new tool ...