FRIDAY, Sept. 14, 2018 -- Lumoxiti injection has been approved to treat certain instances of relapsed or refractory "hairy cell" leukemia, or HCL, the U.S. Food and Drug Administration said Thursday.
Lumoxiti (moxetumomab pasudotox-tdfk) is among a novel class of drugs called CD22-directed cytotoxins to treat HCL, the agency said. It was approved for adults who have had at least two prior therapies for the disease.
"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," said Dr. Richard Pazdur, director of the FDA's Office of Hematology and Oncology Products.
HCL is a slow-growing blood cancer in which the bone marrow makes too many B cells, a type of white blood cell that fights infection, the FDA said. The disease name stems from the extra B cells that appear "hairy" under a microscope.
Lumoxiti was evaluated in a clinical study of 80 people who had been treated previously for HCL. The most common side effects included injection-related reactions, swelling, nausea, fatigue, headache, fever, constipation, anemia and diarrhea.
The drug's label includes a boxed warning of increased risk for capillary leak syndrome, which is characterized by leaking fluid from tiny blood vessels. The warning also notes increased risk of hemolytic uremic syndrome, an abnormal destruction of red blood cells. Breastfeeding women should not take the drug, the FDA urged.
Lumoxiti is produced by AstraZeneca, based in the United Kingdom.More information
The FDA has more about this approval.
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