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Citius Pharmaceuticals Receives Novel FDA Complete Response Letter for LYMPHIRâ„¢ in Cutaneous T-Cell Lymphoma

Citius Pharmaceuticals, has shared a significant update regarding the progress of their product denileukin diftitox ("LYMPHIRTM") through the FDA approval process. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter in response to the Company's application seeking approval for LYMPHIRTM. This innovative substance is an engineered fusion protein that combines interleukin-2 (IL-2) with diphtheria toxin fragments. Its intended use is to treat patients with cutaneous T-cell lymphoma (CTCL) who have experienced relapse or have not responded to previous systemic therapy.

Cutaneous T-cell lymphoma is a category of non-Hodgkin lymphoma that mainly affects the skin, encompassing various subtypes. In CTCL, T-cells, which are immune system cells, become malignant and result in skin lesions. This can cause substantial discomfort, including severe pain and itching. The disease mainly comprises Mycosis Fungoides (MF) and Sézary Syndrome (SS), and its progression can vary widely. Some cases advance slowly, taking years to develop visible tumors, while others progress more rapidly, leading to tumors that can spread to lymph nodes and internal organs, resulting in a grim prognosis. The current treatment landscape involves trying various approaches to manage disease progression, as there is no definitive cure for advanced CTCL except for a small subset of patients eligible for stem cell transplantation.

LYMPHIRTM, or denileukin diftitox-cxdl, is a fusion protein that binds to IL-2 receptors on cell surfaces, subsequently utilizing diphtheria toxin fragments to inhibit protein synthesis within the cells. Citius Pharmaceuticals acquired the exclusive license for developing and commercializing LYMPHIRTM in most markets except for Japan and specific parts of Asia. This update showcases the evolving landscape of CTCL treatment and the innovative strides made by Citius Pharmaceuticals in their pursuit of an effective solution for patients facing this challenging condition.

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