FDA Approves Citius' Lymphir for T-Cell Lymphoma

The US Food and Drug Administration (FDA) has given the green light to Citius Pharmaceuticals’ Lymphir (denileukin diftitox-cxdl) for the treatment of certain cases of cutaneous T-cell lymphoma (CTCL). This immunotherapy is specifically approved for adults with relapsed or refractory CTCL who have previously undergone at least one systemic therapy.

CTCL, a rare form of non-Hodgkin lymphoma, primarily affects the skin, resulting in red, itchy, and scaly patches. The condition impacts approximately 40,000 people in the US. Typically, patients receive a series of skin-directed therapies until their cancer progresses or becomes resistant, at which point systemic treatments become necessary to manage the disease effectively.

Lymphir stands out as the sole CTCL treatment that targets the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs. It is also notable for being the first FDA-approved product for Citius. The FDA’s approval was based on favorable outcomes from a late-stage clinical trial, where Lymphir achieved an objective response rate of 36.2% and a complete response rate of 8.7%. The median time to response was 1.41 months, and around 70% of patients who responded to the treatment saw results after one to two cycles.

Additionally, Lymphir was effective in reducing skin disease in 84.4% of patients, with 12.5% achieving complete clearance of skin disease. The treatment also showed clinically significant improvements in itch, an exploratory endpoint in the study.

Myron Czuczman, Chief Medical Officer at Citius, emphasized the unique benefits of Lymphir. He noted that the therapy’s IL-2 receptor-targeted approach not only directly kills tumor cells but also depletes host Tregs to enhance the body's immune response. Czuczman believes this dual action offers substantial benefits to a significant number of patients with relapsed or refractory CTCL.

Leonard Mazur, Chief Executive Officer at Citius, heralded the approval as a major milestone for CTCL patients. He highlighted that Lymphir's ability to swiftly reduce skin disease and alleviate symptomatic itching without cumulative toxicity is expected to broaden the treatment options available for CTCL.

Mazur also mentioned that Citius is gearing up to introduce Lymphir to the US market within the next five months. The company is committed to collaborating closely with healthcare providers to ensure that all eligible patients have prompt access to this new therapy.