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 not been treated before with other medicines of the same class, known as ALK tyrosine kinase inhibitors (TKIs).
Lorviqua is also used on its own when the disease has worsened despite treatment with other ALK TKIs, including alectinib, ceritinib and crizotinib.
Lorviqua contains the active substance lorlatinib.
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List item
Lorviqua : EPAR - Medicine overview (PDF/111.62 KB)
First published: 17/06/2019
Last updated: 03/02/2022
EMA/779155/2021 -
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Lorviqua : EPAR - Risk-management-plan summary (PDF/47.97 KB)
First published: 17/06/2019
Last updated: 20/10/2022
Authorisation details
Product details | |
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Name |
Lorviqua
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Agency product number |
EMEA/H/C/004646
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Active substance |
Lorlatinib
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International non-proprietary name (INN) or common name |
lorlatinib
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Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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Anatomical therapeutic chemical (ATC) code |
L01ED05
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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
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
06/05/2019
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Contact address |
Boulevard de la Plaine 17 |
Product information
04/04/2023 Lorviqua - EMEA/H/C/004646 - R/0025
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
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Antineoplastic agents
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Protein kinase inhibitors
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) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC whose disease has progressed after:
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