Posted from: Monday, October 08, 2018 - 12:39 PM - Present

Lumoxiti Approved as Novel Treatment for Rare Leukemia

September 13, 2018 – The U.S. FDA has approved Lumoxiti™ (moxetumomab pasudotox-tdfk) injection, manufactured by AstraZeneca, for intravenous use to treat adult patients who have relapsed or refractory hairy cell leukemia (HCL). Patients must have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

A CD22-directed cytotoxin, Lumoxiti is the first treatment of its kind to receive FDA approval for HCL, a slow-growing cancer that begins in the bone marrow. HCL leads to excess production of B cells (lymphocytes), a type of white blood cell that ordinarily helps the body fight off infection. As the cancer cells become more numerous, the body produces fewer healthy white blood cells, red blood cells, and platelets. HCL cells have a characteristic “hairy” shape when viewed under a microscope, which gives the cancer its name.

The FDA approved Lumoxiti following a clinical trial in which 75% of patients who received Lumoxiti had a partial or complete response to treatment. Just under one-third of patients experienced a complete response (full remission).

Lumoxiti carries a black box warning, as patients who receive the treatment may be at risk of developing capillary leak syndrome. The syndrome can lead to difficulty breathing, weight gain, hypotension, or swelling of arms, legs and/or face, as fluids and proteins leak from small blood vessels. There is also a black box warning that Lumoxiti is associated with hemolytic uremic syndrome, caused by the destruction of red blood cells. Patient blood values should be monitored during treatment, and the patient should be advised to drink sufficient amounts of fluids.

AstraZeneca has not yet announced launch or pricing plans.

Last Updated Thursday, October 18, 2018 - 11:18 PM.