Lymphir: A New Treatment for CTCL

Citius Pharmaceuticals has announced that the FDA has approved “LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Lymphir is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs.

What Is Cutaneous T-Cell Lymphoma?

This type of non-hodgkin lymphoma affects the T-cells (a type of white blood cell). It is a type of cancer that appears on the skin and is often misdiagnosed as eczema or psoriasis. It can move from the skin and into the blood and lymph nodes. It affects 2,500-3,000 patients each year.

With this disease, the T-cells develop abnormalities that cause them to attack the skin (which can look like rash-like skin redness, slightly raised or scaly round patches on the skin and skin tumors). Relapsed or refractory patients often have limited treatment options.

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Learn More About CTCL 

What Is Lymphir?

The exact cause of CTCL is unknown and can be challenging to treat. Lymphir is the first to directly target the interleukin-2 receptor (found in some T-lymphocytes). It increases the growth and activity of other T-lymphocytes and B-lymphocytes, and affects the development of the immune system).

• It kills tumor cells directly
• Eliminates host Tregs to build the body’s immune system
• A non-cross existent treatment option
• The median time to response is 1.4 months
• Rapid skin relief

CTCL can cause debilitating skin lesions and severe itching. The approval of Lymphir offers hope for patients and their quality of life. This medication can reduce the disease and control the itching. It targets the malignant T-cells while preserving the healthy tissue. Lymphir is expected to be available within the next 5 months.

The Study That Accelerated Lymphir Approval 

The approval of Lymphir was based on a phase 3 study (NCT01871727). 

• 69 patients who were stage I-III.
• 70% saw results after 1-2 treatment cycles.
• 12.5% saw a complete clearing of skin disease.
• No toxicity was observed.
• Less than 20% experienced side effects: nausea, edema, fatigue, bone pain, rash, chills, constipation.
• Capillary leak syndrome (CLS) can occur and is life-threatening. Patients should be monitored closely.

Conclusion

CTCL is generally first diagnosed between the ages of 50-60 years old. Other than a stem cell transplant (for which few qualify), there is no curative treatment for advanced stages of the disease. The FDA approval of Lymphir offers significant improvement and clinically meaningful benefits for relapsed or refractory CTCL patients.

Keep learning more about cutaneous T-cell lymphoma with our 101 pages! 

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Sources: 

• Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302
• https://citiuspharma.com/pipeline/I-ONTAK/default.aspx