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FDA Approves Immunotherapy to Treat Rare, Debilitating Form of Non-Hodgkin Lymphoma

Early and ongoing funding from LLS helps advance treatments for every type of blood cancer, including this one 


Rye Brook, N.Y., August 15, 2024 – The U.S. Food and Drug Administration recently approved denileukin diftitox-cxdl (Lymphir™) for the treatment of adults with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin lymphoma that mainly affects the skin, but that can also involve the blood, lymph nodes and internal organs in patients with advanced disease.  

“As the first new systemic treatment for CTCL in more than five years, this is a major milestone for patients living with this debilitating and often disfiguring cancer,” says LLS Chief Medical Officer Gwen Nichols, M.D. “People with CTCL tend to try many treatments looking for symptom relief. Cancer can become less responsive after so many treatments, so it’s notable that denileukin was still effective in people in the clinical study who had an average of four, and up 18 previous treatments.”  

The drug works by directly killing tumor cells, while also stimulating an immune response to boost the effect. More than one-third (36.2%) of the 69 patients in a clinical trial responded to the treatment with 8.7% achieving a complete response. Those whose cancer responded to treatment saw a rapid improvement (median 1.4 months) that lasted at least six months for just over half of them. 

LLS funded early research from Francine Foss, M.D., a pioneer in CTCL whose foundational science underpins this important step forward. But there is much more still to be done to improve the quality of life and outcomes for patients with CTCL and all forms of T-cell lymphoma.  

LLS current research funding includes 19 projects looking at ways to bring newer treatments to those who need them. Our funding runs that gamut from grants for laboratory-based research that continues to deepen our understanding of how CTCL attacks the body, to LLS TAP investments in four biotech companies with clinical trials evaluating new treatments for T-cell lymphoma in humans, including BioInvent and Kymera who have trials in patients with CTCL. 

If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists: https://www.lls.org/support-resources/information-specialists