New FDA Approval for LUMOXITITM
|New FDA Approval for LUMOXITITM|
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).
Please see complete Prescribing Information, including Boxed WARNING, Patient Information (Medication Guide), and Instructions for Use
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