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 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.

This EPAR was last updated on 26/02/2019

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
L01XC
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
9
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

18/01/2019 Blincyto - EMEA/H/C/003731 - II/0011

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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