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NICE approve blinatumomab (Blincyto▼) in the treatment of acute lymphoblastic leukaemia

Blincyto▼, for Acute lymphoblastic leukaemia from Amgen

The National Institute for Health and Care Excellence (NICE) have approved Amgen's treatment for acute lymphoblastic leukaemia (ALL) blinatumomab, brand name Blincyto▼.

Blinatumomab is recommended as an option for treating a form of acute lymphoblastic leukaemia called Philadelphia-chromosome-negative, CD19‑positive B‑precursor ALL. The recommendation is specific for adults with minimal residual disease (MRD) of at least 0.1% and only if the disease is in first complete remission.

Minimal residual disease means that there is still some detectable cancer cells in the body

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Why the NICE made these recommendations
Current treatment for acute lymphoblastic leukaemia that is in complete remission with MRD of at least 0.1% is continued chemotherapy followed by haematopoietic stem cell transplantation (HSCT) if possible. Some people with MRD can have HSCT without chemotherapy.

Evidence from 2 clinical studies suggests that blinatumomab may help increase the time people have without their disease relapsing and may lead to more disease being cured. But there are no data directly comparing blinatumomab with continued chemotherapy, with or without HSCT. This means that the exact size of the benefit of blinatumomab compared with continued chemotherapy is uncertain.

About Blincyto (source EMA)
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.

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.

In B-precursor ALL, certain cells that give rise to B cells (a type of white blood cell) multiply too quickly and eventually these abnormal cells replace normal blood cells.

The active substance in Blincyto, blinatumomab, is an antibody that has been designed to attach to a protein (CD19) found on B cells, including ALL cells. It also attaches to a protein (CD3) on T cells (another type of white blood cell).

Blincyto therefore acts as a ‘bridge’ bringing T cells and B cells together and causing the T cells to release substances that eventually kill the cancerous B cells.

Blincyto was first made available in the EU in 2015. It is manufactured by Amgen.

Sources
European Medicines Agency website page for Blincyto
Accessed 26/07/19
Links available in full article

© NICE [2019]

Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity. Technology appraisal guidance [TA589]. Published date: 24 July 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE information on Blincyto

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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