Citius Oncology, Inc., a subsidiary of Citius Pharmaceuticals, has announced the nationwide commercial launch of LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed fusion protein approved by the FDA for treating adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
LYMPHIR offers a potential new treatment option for patients suffering from CTCL, a disease known for severe itching and skin lesions. In clinical trials, LYMPHIR demonstrated a median time to response of 1.4 months and showed an objective response rate of 36.2%, with 84% of evaluable patients experiencing reduced skin tumor burden. The drug also showed meaningful activity in alleviating severe pruritus, a significant quality of life concern for CTCL patients. Importantly, it was not associated with cumulative toxicity.
This approval marks the first FDA-approved systemic therapy for CTCL in more than seven years. LYMPHIR’s mechanism involves targeting IL-2 receptors on tumor cells, delivering diphtheria toxin fragments that inhibit protein synthesis to induce cancer cell death. Additionally, it depletes immunosuppressive regulatory T lymphocytes, offering direct tumoricidal effects without cumulative toxicity.
LYMPHIR is now available across the United States through specialty distributors. Healthcare providers can access treatment resources and prescribing information at www.lymphirhcp.com. The product has a permanent J-code (J9161) to assist reimbursement and streamline claims processing. Support programs include medical education, payer access initiatives, and patient assistance to reduce out-of-pocket costs.
Internationally, Citius Oncology holds exclusive rights to develop and commercialize LYMPHIR, except in India, Japan, and parts of Asia. A recent agreement with Integris Pharma S.A. facilitates named-patient access in Southern European and Balkan countries, supporting global patient access.
Cutaneous T-cell lymphoma is the most common form of cutaneous lymphoma, characterized by cancerous T-cells forming skin lesions that impair patient quality of life due to pain and pruritus. CTCL predominantly affects men in their 50s and 60s and often progresses slowly but can become aggressive at advanced stages. Currently, no curative therapy exists beyond allogeneic stem cell transplantation, which is suitable for only a small subset of patients.
LYMPHIR carries important safety warnings, including a boxed warning for capillary leak syndrome (CLS), which can be life-threatening. CLS occurred in 27% of patients in clinical trials, with symptoms such as edema, hypotension, and hypoalbuminemia. LYMPHIR can also cause serious visual impairment, infusion-related reactions, and hepatotoxicity. Patients require close monitoring throughout treatment, and therapy should be withheld or discontinued depending on the severity of adverse events.
LYMPHIR can cause fetal harm and is not recommended during pregnancy or breastfeeding. Females of reproductive potential should use effective contraception during treatment and for seven days after the last dose. Male fertility may be compromised based on animal studies.
Most common adverse reactions observed include elevated liver enzymes, decreased albumin, nausea, edema, anemia, fatigue, musculoskeletal pain, rash, chills, constipation, fever, and capillary leak syndrome.
Citius Oncology continues to enhance its product offerings and support programs, aiming to broaden the availability and acceptance of LYMPHIR in the growing CTCL market, estimated to exceed $400 million in the U.S. The company also pursues intellectual property protections and potential expanded indications to strengthen its competitive position.
For more information, healthcare providers and patients may visit www.lymphirhcp.com, and further company details can be found at www.citiusonc.com and www.citiuspharma.com.
Reported side effects can be submitted to the FDA or directly to Citius Oncology.
Important safety information and full prescribing details, including boxed warnings, are accessible on the LYMPHIR website.
This announcement contains forward-looking statements subject to risks and uncertainties detailed in Citius Oncology’s SEC filings. Past performance does not guarantee future results.
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