Citius Oncology, a part of Citius Pharmaceuticals, has announced the launch of LYMPHIR™ (denileukin diftitox-cxdl) in the U.S. This new treatment has been approved by the FDA for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL), a type of skin cancer, after they have tried at least one other treatment.
The FDA approved LYMPHIR based on a study that tested its effectiveness and safety in CTCL patients who had already received previous treatments. The study showed that 36.2% of patients responded to the treatment, with 84% of patients experiencing a reduction in their skin tumors.
LYMPHIR also helped reduce severe itching, a common problem for CTCL patients. The treatment showed results in as little as 1.4 months and did not cause the build-up of harmful side effects over time.
LYMPHIR is now available across the U.S. through specialty distributors. Healthcare providers can find treatment resources and prescribing information on a dedicated website: www.lymphirhcp.com. Starting April 1, 2025, LYMPHIR will have a permanent J-code (J9161) to make it easier for healthcare providers to get reimbursement and process claims.
Executive Statement
According to Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals, 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. This is their first marketed product and the culmination of years of development work and commercial preparation.