(RTTNews) - Citius Oncology, Inc. (CTOR), the oncology subsidiary of Citius Pharmaceuticals Inc. (CTXR) announced the U.S. commercial launch of LYMPHIR, a new immunotherapy for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL).
CTCL is a rare form of non-Hodgkin's lymphoma that primarily affects the skin, often causing severe itching and lesions that significantly impact quality of life. Treatment options have been limited, with no FDA-approved systemic therapies available for more than seven years.
LYMPHIR (denileukin diftitox-cxdl), an IL-2 receptor-directed fusion protein, offers a new approach by directly targeting malignant cells while transiently depleting T-regulatory cells. The drug was approved by the FDA on August 7, 2024, marking the first systemic therapy for CTCL in more than seven years.
The FDA approval of LYMPHIR was supported by data from Pivotal Study 302, which enrolled patients with Stage I-III CTCL who had received at least one prior systemic therapy.
The study demonstrated an Objective Response Rate of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden.
Importantly, LYMPHIR also provided meaningful relief from severe pruritus, a major quality-of-life issue for CTCL patients. Median time to response was just 1.4 months, and the therapy was not associated with cumulative toxicity.
"This is our first marketed product and the culmination of years of development work", said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "LYMPHIR addresses a clear clinical need in a disease with limited treatment options. We believe it will be a meaningful addition to the treatment paradigm for CTCL and a catalyst for shareholder value".
Citius estimates that LYMPHIR is entering a U.S. market valued at over $400 million, with further growth opportunities through international expansion and potential label extensions. The company's immediate focus is on execution to ensure the therapy reaches patients who need it most.
Dr. Myron Czuczman, Chief Medical Officer of Citius Oncology, emphasized LYMPHIR's unique profile: "It is the only FDA-approved systemic therapy for CTCL in more than seven years. Its direct tumoricidal activity and transient T-regulatory cell depletion provide a powerful new approach to disease control without cumulative toxicity".
CTOR closed yesterday's trading session at $1.64, up 19.71%, before slipping to $1.55 in overnight trading, down 5.49%. Over the past 12 months the stock has traded between $1.40 to $1.83.
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