Table of contents
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.
Blincyto : EPAR - Medicine overview (PDF/143.61 KB)
First published: 07/12/2015
Last updated: 13/07/2021
Blincyto : EPAR - Risk-management-plan summary (PDF/95.9 KB) (updated)
First published: 07/12/2015
Last updated: 08/05/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Precursor Cell Lymphoblastic Leukemia-Lymphoma
|Anatomical therapeutic chemical (ATC) code||
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.
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.
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
4817 ZK Breda
09/03/2023 Blincyto - EMEA/H/C/003731 - IB/0050
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 202016/10/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201816/11/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015