Lumykras
sotorasib
Table of contents
Overview
Lumykras is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced, and its cells have a particular genetic change. The change is in the gene KRAS and is known as ‘KRAS G12C’. Lumykras is given when the disease has progressed after receiving systemic treatment (treatment affecting the whole body).
Lumykras contains the active substance sotorasib.
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Lumykras : EPAR - Medicine Overview (PDF/136.1 KB)
First published: 31/03/2022
EMA/685702/2021 -
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Lumykras : EPAR - Risk management plan summary (PDF/281.01 KB)
First published: 31/03/2022
Authorisation details
Product details | |
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Name |
Lumykras
|
Agency product number |
EMEA/H/C/005522
|
Active substance |
sotorasib
|
International non-proprietary name (INN) or common name |
sotorasib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01XX73
|
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 |
Amgen Europe BV
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
06/01/2022
|
Contact address |
Minervum 7061 |
Product information
15/09/2022 Lumykras - EMEA/H/C/005522 - II/0003
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
Antineoplastic agents
Therapeutic indication
Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.