FDA Approves IV Injection for Hairy Cell Leukemia

The US Food and Drug Administration (FDA) granted approval to an intravenous (IV) injection for the treatment of certain adult patients with relapsed or refractory hairy cell leukemia (HCL).

Lumoxti (moxetumomab pasudotox-tdfk; AstraZeneca Pharmaceuticals), a CD22-directed cytotoxin, is now approved for the treatment of adult patients with relapsed or refractory HCL who have received at least 2 prior systemic therapies, including treatment with a purine nucleoside analog. This approval marks the first for this type of treatment in HCL.

This approval is based on a single-arm, open-label clinical trial of 80 patients that measured durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR. Results of the trial showed that 30% of patients achieved durable CR; the overall response rate (number of patients with partial or complete response to therapy) was 75%.

Common adverse events associated with Lumoxti include infusion-related reactions, swelling caused by excess fluid in body tissue, nausea, fatigue, headache, fever, constipation, anemia, and diarrhea.

“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 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, in an FDA press release (September 13, 2018).

 “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,” he added.

—Janelle Bradley

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