An overview of Alecensa and why it is authorised in the EU
Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).
Alecensa is used on its own and only if the NSCLC is ‘ALK-positive’, which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Alecensa contains the active substance alectinib.
Alecensa : EPAR - Summary for the public (PDF/77.1 KB)
First published: 11/04/2017
Last updated: 05/07/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Non-Small-Cell Lung
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
09/08/2018 Alecensa - EMEA/H/C/004164 - N/0017
- 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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Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Alecensa as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC previously treated with crizotinib.