# Alectinib

Source: https://onco.cc/drugs/alectinib/  
OnCo record `alectinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Alectinib is a well-tolerated ALK pill, standard first line for years and, since 2024, the first targeted therapy given after surgery for ALK-positive lung cancer.

## Summary

Alectinib is an ATP-competitive second-generation ALK inhibitor that penetrates the central nervous system and spares ROS1. It is the long-standing first-line standard for ALK-positive non-small-cell lung cancer and, since 2024, the first targeted therapy given after surgery for resected ALK-positive disease. ALEX (2017) showed PFS of 34.8 versus 10.9 months against crizotinib with strong CNS control, and ALINA (2024) showed adjuvant alectinib cut recurrence by 76% versus chemotherapy (DFS HR 0.24 in stage II to IIIA). Its first-line position is being challenged by lorlatinib (CROWN) and, in the ALKAZAR trial, by neladalkib, so the open question is which ALK inhibitor to use first. For a newcomer, alectinib is the well-tolerated ALK pill that most patients start on and that now also protects against relapse after an operation.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Brand: Alecensa
- Modality: Small-molecule kinase inhibitor (ALK)
- Mechanism: ATP-competitive second-generation ALK inhibitor, CNS-penetrant, spares ROS1.
- Approvals: US 2015: ALK+ NSCLC after crizotinib; US 2017: First-line ALK+ NSCLC; US 2024: Adjuvant ALK+ NSCLC after resection (stage IB ≥4 cm to IIIA); England (NICE) 2018: Untreated ALK-positive advanced non-small-cell lung cancer

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Alectinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Alectinib
- NICE TA536: alectinib for untreated ALK-positive advanced non-small-cell lung cancer: https://www.nice.org.uk/guidance/ta536

## Connected records

- biomarkers: [ALK fusion (ALK-positive)](https://onco.cc/biomarkers/alk-fusion/)
- cancers: [ALK-positive non-small-cell lung cancer](https://onco.cc/cancers/alk-positive-nsclc/), [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [Inflammatory myofibroblastic tumour (IMT)](https://onco.cc/cancers/inflammatory-myofibroblastic-tumour/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Paediatric high-grade glioma (excluding diffuse midline glioma)](https://onco.cc/cancers/paediatric-high-grade-glioma/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [ALK](https://onco.cc/targets/alk/)
- companies: [Chugai Pharmaceutical](https://onco.cc/companies/chugai/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small C](https://onco.cc/trials/nct05170204/), [A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors](https://onco.cc/trials/nct04774718/), [A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct04302025/), [A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct03178552/), [ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials)](https://onco.cc/trials/alchemist/), [ALESIA](https://onco.cc/trials/alesia/), [ALEX](https://onco.cc/trials/alex/), [ALINA](https://onco.cc/trials/alina/), [CUPISCO](https://onco.cc/trials/cupisco/), [Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements](https://onco.cc/trials/nct05987644/), [DETERMINE](https://onco.cc/trials/determine-trial/), [J-ALEX](https://onco.cc/trials/j-alex/), [MyPathway](https://onco.cc/trials/mypathway/), [Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC](https://onco.cc/trials/nct06765109/), [Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms](https://onco.cc/trials/nct05987956/), [PROFILE 1014](https://onco.cc/trials/profile-1014/), [Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer](https://onco.cc/trials/nct05725200/), [Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study](https://onco.cc/trials/nct04589845/)
- drugs: [Neladalkib](https://onco.cc/drugs/neladalkib/)
- key papers: [Alectinib in resected ALK-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-wu-alina-adjuvant-alectinib-nejm-2024/), [Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-peters-alex-alectinib-crizotinib-nejm-2017/), [Identification of targetable ALK rearrangements in pancreatic ductal adenocarcinoma](https://onco.cc/key-papers/paper-singhi-alk-rearrangements-pancreatic-jnccn-2017/), [Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer](https://onco.cc/key-papers/paper-gainor-alk-resistance-mutations-cancer-discov-2016/)
- terms: [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/)
- ideas: [Prevention trials aimed only at brain metastasis](https://onco.cc/ideas/idea-bio2-brain-met-prevention-trials/)
- pathways: [Non-small cell lung cancer (KEGG map)](https://onco.cc/pathways/nsclc-signalling/), [Receptor tyrosine kinase activation](https://onco.cc/pathways/rtk-activation/), [The blood-brain barrier & brain metastasis](https://onco.cc/pathways/blood-brain-barrier-metastasis/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

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