Daurismo

RSS

glasdegib

Authorised
This medicine is authorised for use in the European Union.

Overview

Daurismo is a cancer medicine for treating adults with newly-diagnosed acute myeloid leukaemia (AML), a cancer of white blood cells.

It is used in combination with a low dose of cytarabine (another cancer medicine) when the patient cannot be treated with standard chemotherapy.

The active substance in Daurismo is glasdegib.

Acute myeloid leukaemia is rare, and Daurismo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 October 2017.

This EPAR was last updated on 10/07/2020

Authorisation details

Product details
Name
Daurismo
Agency product number
EMEA/H/C/004878
Active substance
Glasdegib maleate
International non-proprietary name (INN) or common name
glasdegib
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
L01XX63
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
26/06/2020
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

26/06/2020 Daurismo - EMEA/H/C/004878 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed

de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for

standard induction chemotherapy.

Assessment history

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