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Moxetumumab pasudotox-tdfk is FDA approved for adults with relapsed or refractory hairy cell leukemia. They must have had at least two prior systemic therapies. One of these must be a purine nucleoside analog (PNA).The approval was based on Study 1053 (NCT01829711).
The EMA lists Lumoxiti TM as authorized in the EU. It's for monotherapy in adults with relapsed or refractory HCL. They must have had at least two prior treatments, including a PNA. The EU granted marketing authorization on February 8, 2…