Citius Oncology has secured a key distribution partnership with Cardinal Health to support the commercial launch of LYMPHIR, its FDA-approved immunotherapy for cutaneous T-cell lymphoma. The agreement positions the company to deliver its targeted therapy to patients with this rare and challenging cancer.
Strategic Distribution Partnership
Under the distribution services agreement announced June 9, 2025, Cardinal Health will serve as an authorized distributor of record for Citius Oncology, providing specialty pharmaceutical distribution services for LYMPHIR (denileukin diftitox-cxdl). The partnership is designed to ensure efficient and reliable access to the therapy for healthcare providers and patients across the United States.
"This agreement marks a key step forward in our launch readiness efforts," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "Cardinal Health's proven distribution capabilities will help ensure LYMPHIR reaches healthcare providers and patients efficiently and reliably, as we work to build a robust commercial distribution network."
LYMPHIR's Therapeutic Profile
LYMPHIR represents a targeted immune therapy for patients with relapsed or refractory cutaneous T-cell lymphoma, specifically indicated for Stage I-III disease after at least one prior systemic therapy. The drug is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments, specifically binding to IL-2 receptors on cell surfaces and inhibiting protein synthesis to cause cell death.
The therapy demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and showed antitumor activity through direct cytocidal action on IL-2R-expressing tumors. LYMPHIR received FDA approval in August 2024, following earlier regulatory approval in Japan in 2021 for the treatment of CTCL and PTCL.
Market Opportunity and Unmet Need
Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and remains underserved by existing therapies. Cutaneous T-cell lymphoma affects men twice as often as women and is typically first diagnosed in patients between ages 50 and 60. The disease can progress slowly over several years to a decade before potentially reaching tumor stage, at which point it becomes highly malignant and can spread to lymph nodes and internal organs.
Given the chronic nature of the disease, patients typically cycle through multiple agents to control disease progression. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.
Safety Profile and Clinical Experience
LYMPHIR carries a boxed warning for capillary leak syndrome (CLS), which occurred in 27% of patients across three clinical trials, including 8% with Grade 3 severity. There was one fatal occurrence of CLS (0.8%). The majority of CLS events (81%) occurred within the first two cycles of treatment, with a median time to onset of 6.5 days and median duration of 14 days.
Other significant adverse events include visual impairment (9% of patients), infusion-related reactions (69% of patients), and hepatotoxicity, with elevated ALT occurring in 70% of patients and Grade 3 ALT elevation in 22%. The most common adverse reactions include increased transaminases, decreased albumin, nausea, edema, decreased hemoglobin, fatigue, musculoskeletal pain, rash, chills, constipation, and pyrexia.
Clinical Trial Data
In the pooled safety population of 69 patients with Stage I-III relapsed or refractory CTCL who received LYMPHIR, 49% were 65 years of age and older, and 14% were 75 years of age and older. Of patients experiencing visual impairment, 67% had resolution of their symptoms.
Competitive Positioning
Citius Oncology's competitive positioning is supported by robust intellectual property protections spanning orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors. The company acquired exclusive licensing rights to develop and commercialize LYMPHIR in all markets except Japan and certain parts of Asia in 2021.
