Lorviqua
lorlatinib
Table of contents
Overview
Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive’, which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.
Lorviqua contains the active substance lorlatinib.
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Lorviqua : EPAR - Medicine overview (PDF/109.97 KB)
First published: 17/06/2019
Last updated: 25/09/2020
EMA/459090/2020 -
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Lorviqua : EPAR - Risk-management-plan summary (PDF/159.58 KB)
First published: 17/06/2019
Authorisation details
Product details | |
---|---|
Name |
Lorviqua
|
Agency product number |
EMEA/H/C/004646
|
Active substance |
Lorlatinib
|
International non-proprietary name (INN) or common name |
lorlatinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01
|
Additional monitoring |
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. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
06/05/2019
|
Contact address |
Product information
17/12/2020 Lorviqua - EMEA/H/C/004646 - II/0008
Contents
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) whose disease has progressed after:
- alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
- crizotinib and at least one other ALK TKI.