This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 29/11/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
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
Amgen Europe BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Minervum 7061
4817ZK Breda
The Netherlands

Product information

15/09/2022 Lumykras - EMEA/H/C/005522 - II/0003

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Product information documents contain:

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.

Assessment history

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