Core Insights - Citius Oncology has launched LYMPHIR, a novel treatment for relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL), which has been approved by the FDA [1][11] - The product is expected to address a significant clinical need in a market valued at over $400 million, with potential for international expansion and additional indications [2][13] Product Overview - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy that combines the IL-2 receptor binding domain with diphtheria toxin fragments, specifically designed to treat CTCL after at least one prior systemic therapy [10][16] - The FDA approval was based on Pivotal Study 302, which showed an Objective Response Rate (ORR) of 36.2% and a median time to response of 1.4 months [3][11] Clinical Benefits - LYMPHIR offers rapid skin relief and has shown meaningful activity against severe pruritus, a common issue for CTCL patients [2][4] - The treatment is noted for its lack of cumulative toxicity, making it a compelling option for patients and physicians [4][10] Market Potential - The U.S. market for LYMPHIR is estimated to exceed $400 million and is expected to grow, indicating a strong demand for effective CTCL therapies [2][13] - Citius Oncology has exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia, with plans for international distribution [7][11] Commercial Strategy - LYMPHIR is available through specialty distributors in the U.S., with a dedicated portal for healthcare providers to access treatment resources [5][9] - The launch is supported by medical education and payer access programs, and LYMPHIR has been included in the National Comprehensive Cancer Network (NCCN) Guidelines for CTCL [6][7] Company Background - Citius Oncology is focused on developing and commercializing novel targeted oncology therapies, with LYMPHIR being its first marketed product [13][14] - The company has robust intellectual property protections and is actively engaged in expanding its market presence [13][14]