Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory).
Blincyto is also used in adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body).
Blincyto is used in patients who are ‘Philadelphia-chromosome-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 contains the active substance blinatumomab and is used on its own.
ALL is rare, and Blincyto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 July 2009.
Blincyto : EPAR - Medicine overview (PDF/113.86 KB)
First published: 07/12/2015
Last updated: 26/02/2019
Blincyto : EPAR - Risk-management-plan summary (PDF/128.5 KB)
First published: 07/12/2015
Last updated: 07/12/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Precursor Cell Lymphoblastic Leukemia-Lymphoma
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
21/10/2019 Blincyto - EMEA/H/C/003731 - IB/0032
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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BLINCYTO is indicated for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
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 hematopoietic stem cell transplantation.
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