2:02 PM
Sep 13, 2018
 |  BC Extra  |  Company News

FDA approves AZ's hairy cell leukemia drug

FDA approved Lumoxiti moxetumomab pasudotox-tdfk from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat relapsed or refractory hairy cell leukemia in adults who have received at least two prior systemic therapies, including a purine nucleoside analog.

Lumoxiti, an anti-CD22 antibody variable fragment fused to the PE38 immunotoxin, has Orphan Drug status from FDA.

The drug's label includes a boxed warning about the risks of capillary leak syndrome and hemolytic uremic syndrome.

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