FDA has approved AstraZeneca Pharmaceuticals’ Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for treating 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. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL, according to an agency release. HCL is a rare, slow-growing blood cancer in which bone marrow makes too many B cells (lymphocytes), a type of white blood cell that fights infection. “As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells and platelets are produced,” FDA says.
Approval was based on data from 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. Thirty percent of patients in the trial achieved durable complete response, and the overall response rate (number of patients with partial or complete response to therapy) was 75%, the agency says. Common side effects included infusion-related reactions, swelling caused by excess fluid in body tissue (edema), nausea, fatigue, headache, fever (pyrexia), constipation, anemia and diarrhea. A Boxed Warning is also required to advise health care 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.