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Lumoxiti Approval History

FDA Approved: Yes (First approved September 13, 2018)
Brand name: Lumoxiti
Generic name: moxetumomab pasudotox-tdfk
Dosage form: Injection
Company: AstraZeneca
Treatment for: Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox-tdfk) is an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.

Development History and FDA Approval Process for Lumoxiti

DateArticle
Sep 13, 2018Approval FDA Approves Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia
Jun  2, 2018Moxetumomab Pasudotox Pivotal Data in Patients with Previously-Treated Hairy Cell Leukemia Presented at the 2018 ASCO Meeting
Apr  3, 2018US FDA Accepts Biologics License Application for Moxetumomab Pasudotox in Hairy Cell Leukemia

Further information

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