Is Moxetumomab pasudotox approved by the US FDA?

Drugs@FDA lists 1 application product line for Moxetumomab pasudotox, including LUMOXITI (Prescription).

Is Moxetumomab pasudotox authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Moxetumomab pasudotox.

Are there safety signals or safety updates for Moxetumomab pasudotox?

US FDA: 1 entry (latest 2020-08-20).

Active substance

Moxetumomab pasudotox

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LUMOXITI	1MG/VIAL	injectable · injection	INNATE PHARMA	Prescription	13 Sep 2018

EMA European Union — centrally authorised medicines

Lumoxiti AstraZeneca AB · Withdrawn · authorised 8 Feb 2021 · ATC L01X

Therapeutic indication (EMA)

Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA).

Safety signals and safety-related labeling changes

US FDA 20 Aug 2020 LUMOXITI — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for moxetumomab pasudotox →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.