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FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia


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ON SEPTEMBER 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

Richard Pazdur, MD

Richard Pazdur, MD

“[Moxetumomab pasudotox-tdfk] 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 the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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 moxetumomab pasudotox-tdfk was assessed in Study 1053, a single-arm, open-label clinical trial of 80 patients who had received prior treatment for HCL with at least two systemic therapies, including a purine nucleoside analog. The trial measured durable complete response, defined as maintenance of hematologic remission for more than 180 days after achievement of a complete response. Thirty percent of patients in the trial achieved a durable complete response, and the overall response rate was 75%.

The recommended dose of moxetumomab pasudotox-tdfk is 0.04 mg/kg administered as a 30-minute intravenous infusion on days 1, 3, and 5 of each 28-day cycle for a maximum of 6 cycles or until occurrence of disease progression or unacceptable toxicity.

Safety Profile

COMMON SIDE effects of moxetumomab pasudotox-tdfk include infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea.

The prescribing information for moxetumomab pasudotox-tdfk includes a boxed warning about the risk of developing capillary leak syndrome. The boxed warning also notes the risk of hemolytic uremic syndrome, a condition caused by the abnormal destruction of red blood cells. Patients should be made aware of the importance of maintaining adequate fluid intake, and blood chemistry values should be monitored frequently. Other serious warnings include decreased renal function, infusion-related reactions, and electrolyte abnormalities. Women who are breastfeeding should not be given moxetumomab pasudotox-tdfk. ■


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