Lumoxiti (moxetumomab pasudotox)
- Region
- 🇪🇺 EU
- Active substance
- moxetumomab pasudotox
- Company
- AstraZeneca AB
- Status
- Withdrawn
- Therapeutic area
- Leukemia, Hairy Cell
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Mon 08 Feb 2021
- Application
- EMEA/H/C/005322
- ATC
- L01X
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.