Alectinib
Anaplastic Lymphoma Kinase (Alk) Inhibitors
Sold as Alecensa · ALECENSARO
- Drug class
- Anaplastic Lymphoma Kinase (Alk) Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 9
Overview
Alectinib is an active pharmaceutical ingredient in the Anaplastic Lymphoma Kinase (Alk) Inhibitors group (L01ED). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | May 15, 2026 |
| EU European Union | EMA | 1 | March 31, 2026 |
| CA Canada | Health Canada | 1 | March 26, 2025 |
GBUnited Kingdom· MHRA
7 products
Uses
Adjuvant Treatment of Resected Non-Small Cell Lung Cancer Alecensa as monotherapy is indicated as adjuvant treatment for adult patients with Stage IB (tumours ≥4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection Treatment of Advanced Non-Small Cell Lung Cancer 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.
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
Uses
ALECENSARO (alectinib) is indicated: • for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). • as monotherapy for the treatment of patients with ALK-positive, locally advanced (not amenable to curative therapy) or metastatic NSCLC who have progressed on or are intolerant to crizotinib.
Marketing authorization of ALENCENSARO for this indication is primarily based on tumour objective response rate and duration of response; no overall survival benefit has been demonstrated (see 14 CLINICAL TRIALS). • for adjuvant treatment following tumour resection for patients with stage IB (tumours ≥ 4 cm) to IIIA* ALK-positive NSCLC.
1 Pediatrics (< 18 years of age) Pediatrics (< 18 years of age): The safety and efficacy of ALECENSARO in children and adolescents have not yet been established. Therefore, Health Canada has not authorized an indication for pediatric use.
Drug interactions
Known interactions involving Alectinib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB000310843 · revised April 17, 2026
- [2]European Medicines Agency · EMEA/H/C/004164 · revised March 31, 2026
- [3]Health Canada (DPD) · 02458136 · revised March 26, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.