Lorviqua

RSS

lorlatinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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 monitoringAdditional 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 approvalConditional 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
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
06/05/2019
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

Lorviqua - EMEA/H/C/004646 -

Contents

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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.

Assessment history

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