Citius Pharmaceuticals Receives FDA Approval for Lymphir
Citius Pharmaceuticals Inc. (CTXR) secured FDA approval on Thursday for Lymphir (denileukin diftitox-cxdl) to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. This marks a significant milestone for the company, as Lymphir becomes the first FDA-approved product in its portfolio.
Lymphir stands out as the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This unique mechanism of action holds promise for expanding the treatment landscape for CTCL, a rare and often debilitating chronic non-Hodgkin lymphoma primarily affecting the skin. Approximately 2,500-3,000 patients are diagnosed with CTCL each year, with an estimated 40,000 living with the disease.
The approval of Lymphir is based on data from a phase 3 trial demonstrating an overall response rate of 36%. Notably, 52.0% of patients experienced a duration of response lasting at least six months. Additionally, 84.4% of skin evaluable subjects saw a decrease in skin tumor burden, and 12.5% achieved complete clearing of skin disease. Furthermore, 31.7% of patients showed clinically significant improvement in pruritis, highlighting the potential of Lymphir to alleviate the debilitating symptom of itching associated with CTCL.
Citius plans to launch Lymphir in the U.S. market within the next five months, aiming to capitalize on the estimated $300 to $400 million CTCL market. This approval marks a significant achievement for the company, paving the way for potential growth and expansion in the years to come.