Lumykras

RSS

sotorasib

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

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.

This EPAR was last updated on 31/03/2022

Authorisation details

Product details
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 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.

Publication details
Marketing-authorisation holder
Amgen Europe BV
Date of issue of marketing authorisation valid throughout the European Union
06/01/2022
Contact address

Minervum 7061
4817ZK Breda
The Netherlands

Product information

Lumykras - EMEA/H/C/005522 -

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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