Ceritinib

Ceritinib (Zykadia, Novartis Europharm Limited) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (2).
Approved indications of Ceritinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
ALK fusion
Monotherapy
1L
advanced
None
ALK fusion
Monotherapy
2L
advanced
Previously treated with crizotinib
Full text of section 4.1 (therapeutic indications)

Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Label history

25 changes to the Zykadia label since 2015, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes