Citius Oncology, a subsidiary of Citius Pharmaceuticals, has launched the first new FDA-approved systemic therapy for relapsed or refractory Stage I–III cutaneous T-cell lymphoma in over seven years.

The launch of LYMPHIR (denileukin diftitox-cxdl), a novel IL-2 receptor-directed fusion protein, offers rapid relief from severe itching and skin symptoms, giving patients a much-needed treatment option.

"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.

Mazur called the launch “the culmination of years of development work and commercial preparation” and highlighted LYMPHIR’s potential impact: "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."

"LYMPHIR is an important new tool in the fight against CTCL. It is the only FDA-approved systemic therapy for CTCL in more than seven years," said Dr Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma.

"LYMPHIR's direct tumoricidal activity and transient T-regulatory cell depletion offer a powerful new approach to disease control without cumulative toxicity. As such, LYMPHIR's clinical profile makes it a compelling treatment option for physicians and patients facing the burden of relapsed or refractory CTCL."