Table of contents
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
Alecensa : EPAR - Risk-management-plan summary (PDF/203.75 KB)
First published: 11/10/2021
Last updated: 23/01/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Non-Small-Cell Lung
|Anatomical therapeutic chemical (ATC) code||
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.
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
15/03/2023 Alecensa - EMEA/H/C/004164 - N/0046
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.