An overview of Imbruvica and why it is authorised in the EU
Imbruvica is a medicine for treating adult patients with the following blood cancers:
- chronic lymphocytic leukaemia (CLL) in previously untreated patients and in patients who have received at least one previous treatment;
- mantle cell lymphoma in patients whose disease does not respond to or has come back after previous treatment;
- Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma) in patients who have had previous treatment or who cannot have chemo immunotherapy.
Imbruvica is usually used on its ownto treat these cancers . For CLL, it can be given with two other cancer medicines, bendamustine and rituximab, in patients who have received previous treatment.
These diseases are rare, and Imbruvica was designated an ‘orphan medicine’ (a medicine used in rare diseases) for chronic lymphocytic leukaemia on 26 April 2012, mantle cell lymphoma on 12 March 2013 and Waldenström’s macroglobulinaemia on 29 April 2014.
Further information on the orphan designations can be found on the European Medicines Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Imbruvica contains the active substance ibrutinib.
Imbruvica : EPAR - Summary for the public (PDF/126.25 KB)
First published: 25/11/2014
Last updated: 30/08/2018
Imbruvica : EPAR - Risk-management-plan summary (PDF/93.9 KB)
First published: 25/11/2014
Last updated: 25/11/2014
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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.
Janssen-Cilag International NV
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29/06/2018 Imbruvica - EMEA/H/C/003791 - X/0037
- 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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Protein kinase inhibitors
Imbruvica is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Imbruvica as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Imbruvica is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Imbruvica is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy.