FDA okayed a first-of-its-kind treatment for hairy cell leukemia (HCL).
Moxetumomab pasudotox-tdfk (Lumoxiti, AstraZeneca and MedImmune) injection for IV use os a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL. It is indicated for adult patients with relapsed or refractory hairy cell HCL who have received at least 2 prior systemic therapies, including treatment with a purine nucleoside analog.
Lumoxiti is the first FDA-approved medicine for HCL in more than 20 years, said Dave Fredrickson, executive vice president and global head of AstraZeneca’s Oncology Business Unit, in a statement from AstraZeneca.
“Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in a statement. “This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”
The efficacy of Lumoxiti was studied in a clinical trial of 80 patients who had received prior treatment for HCL with at least 2 systemic therapies, including a purine nucleoside analog. Thirty percent of patients in the trial achieved durable CR, and the overall response rate (number of patients with partial or complete response to therapy) was 75%.
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The prescribing information for Lumoxiti includes a Boxed Warning to advise healthcare professionals and patients about the risk of developing capillary leak syndrome, a condition in which fluid and proteins leak out of tiny blood vessels into surrounding tissues.
Other serious warnings include: decreased renal function, infusion-related reactions and electrolyte abnormalities. In addition, women who are breastfeeding should not be given Lumoxiti.