Blincyto

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blinatumomab

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

Overview

Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above one year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory). It can also be used in these patients as part of ‘consolidation therapy’, to improve the remission.

Blincyto is also used in adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they have some detectable cancer cells in their body).

Blincyto is used in patients who are ‘Philadelphia-chromosome-negative’ (Ph-negative) which means that the patients’ cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).

Blincyto can also be used in patients who are ‘Philadelphia-chromosome-positive’ (Ph-positive) if their cancer has not responded to previous treatment with at least two medicines called tyrosine kinase inhibitors and they have no alternative treatment options. Blincyto contains the active substance blinatumomab.

ALL is rare, and Blincyto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 July 2009. Further information on the orphan designation can be found here.

This EPAR was last updated on 08/05/2023

Authorisation details

Product details
Name
Blincyto
Agency product number
EMEA/H/C/003731
Active substance
blinatumomab
International non-proprietary name (INN) or common name
blinatumomab
Therapeutic area (MeSH)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code
L01FX07
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
Amgen Europe B.V.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
23/11/2015
Contact address
Minervum 7061
4817 ZK Breda
The Netherlands

Product information

09/03/2023 Blincyto - EMEA/H/C/003731 - IB/0050

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.

BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy (see section 4.2).

Assessment history

Changes since initial authorisation of medicine

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