Adagrasib

Adagrasib (Krazati, Bristol-Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: KRAS (1).
Approved indications of Adagrasib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
KRAS G12C
Monotherapy
2L
advanced
Disease progression after at least one prior systemic therapy
Full text of section 4.1 (therapeutic indications)

KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.

Label history

5 changes to the Krazati label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes