Basic Information
Blincyto
Regulatory Information
EMEA/H/C/003731
November 23, 2015
September 24, 2015
23
March 20, 2024
Company Information
the netherlands
Minervum 7061 4817 ZK Breda
AMGEN EUROPE B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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).
Overview Summary
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](/en/medicines/human/orphan-designations/eu-3-09-650).