FDA Approves Treatment for Relapsed/Refractory Hairy Cell Leukemia

The U.S. Food and Drug Administration approved moxetumomab pasudotox-tdfk injection for the treatment of relapsed/refractory hairy cell leukemia (HCL) in adults who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. This CD22-directed cytotoxin is the first of this type of treatment for HCL. 

The approval was based on results from a single-arm, open-label clinical trial that included 80 patients who had received prior treatment for HCL. Thirty percent of patients in the trial achieved durable complete response, and the overall response rate was 75 percent. 

FDA approves new kind of treatment Lumoxiti (moxetumomab pasudotox-tdfk) for hairy cell leukemia https://t.co/ZCx82Z6qrG

— Anthony M Crasto DR. (@amcrasto) September 14, 2018

The most common adverse events associated with moxetumomab pasudotox-tdfk are infusion-related reactions (IRRs), edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea. 

The drug carries a Boxed Warning on the risk of developing capillary leak syndrome, symptoms of which include difficulty breathing, weight gain, hypotension, or swelling of arms, legs, and/or face. The Boxed Warning also notes the risk of hemolytic uremic syndrome.  

FDA Approves #Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia #newdrugs – https://t.co/mWvowjMlDy

— Drugs.com (@Drugscom) September 13, 2018

Patients should be counseled on maintaining adequate fluid intake, and physicians should regularly monitor blood chemistry values. Other serious warnings include decreased renal function, IRRs, and electrolyte abnormalities.  

Is there a link between maternal hormonal birth control use and childhood leukemia? 

Diabetes is associated with a higher cancer risk in women, but not men. 

Source: FDA