Core Insights - Citius Oncology has finalized an exclusive agreement with EVERSANA to support the commercialization of LYMPHIR, an FDA-approved therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), expected to launch in Q4 2025 [1][4][27] Company Overview - Citius Oncology is a subsidiary of Citius Pharmaceuticals, focused on developing and commercializing targeted oncology therapies. The company’s primary asset, LYMPHIR, received FDA approval in August 2024 for treating adults with relapsed or refractory CTCL after at least one prior systemic therapy [27][28] - Citius Oncology estimates the initial market for LYMPHIR exceeds $400 million and is growing, indicating a significant opportunity in an underserved market [27] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy indicated for adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy. It works by binding to IL-2 receptors on malignant T-cells, leading to cell death [6][8][27] - The therapy has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes and exhibit antitumor activity [7] Commercialization Strategy - Under the Master Service Agreement, EVERSANA will provide an integrated suite of pre- and post-launch operations services, including medical information, pharmacovigilance, revenue cycle management, and data analytics [2][3] - This partnership is expected to enhance Citius Oncology's operational readiness and market access for LYMPHIR, aligning with investor expectations [4][29] Market Context - Cutaneous T-cell lymphoma is the most common type of cutaneous lymphoma, with a significant impact on patients' quality of life due to severe symptoms. The disease primarily affects men aged 50 to 60 [5][27] - Current treatment options for advanced CTCL are limited, with no curative therapies available other than allogeneic stem cell transplantation for a small fraction of patients [5]
Citius Oncology Signs Exclusive Commercialization Agreement with EVERSANA to Support Planned Q4 2025 Launch of LYMPHIR™