Sotorasib

Sotorasib (Lumykras, Amgen Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: KRAS (1).
Approved indications of Sotorasib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
KRAS G12C
Monotherapy
2L
advanced
After at least one prior line of systemic therapy
Full text of section 4.1 (therapeutic indications)

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.

Label history

8 changes to the Lumykras label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes