Alectinib

Alectinib (Alecensa, Roche Registration GmbH) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (3).
Approved indications of Alectinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer3
ALK fusion
Monotherapy
Adj.
After complete tumour resection; High risk of recurrence
ALK fusion
Monotherapy
1L
advanced
None
ALK fusion
Monotherapy
2L
advanced
Previously treated with crizotinib
Full text of section 4.1 (therapeutic indications)

Adjuvant treatment of resected non-small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria). Treatment of advanced NSCLC Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC. Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.

Label history

18 changes to the Alecensa label since 2017, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes