{"entity":{"id":"alectinib","kind":"drug","name":"Alectinib","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-06","wikipedia":"https://en.wikipedia.org/wiki/Alectinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Alectinib"},{"label":"NICE TA536: alectinib for untreated ALK-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta536"}],"tags":[],"related":["alk-fusion"],"cancers":["nsclc","alk-positive-nsclc","resectable-nsclc","lung-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["alina","nct05170204","nct06765109","nct03178552","nct04302025","nct04774718","nct05987956","alex","alesia","profile-1014"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Alecensa","modality":"Small-molecule kinase inhibitor (ALK)","mechanism":"ATP-competitive second-generation ALK inhibitor, CNS-penetrant, spares ROS1.","approvals":[{"region":"US","year":2015,"indication":"ALK+ NSCLC after crizotinib"},{"region":"US","year":2017,"indication":"First-line ALK+ NSCLC"},{"region":"US","year":2024,"indication":"Adjuvant ALK+ NSCLC after resection (stage IB ≥4 cm to IIIA)"},{"region":"England (NICE)","year":2018,"indication":"Untreated ALK-positive advanced non-small-cell lung cancer","note":"TA536, published 8 August 2018, within its marketing authorisation subject to the commercial arrangement (ALEX)."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2015-12-11","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib"},{"date":"2017-11-06","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2015 converted to traditional approval 1.9 years after it was granted.","indication":"ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib"}]},"route":"/drugs/alectinib/","neighbours":{"biomarker":[{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"}],"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"secondary-brain-tumours","kind":"cancer","name":"Brain metastases (secondary brain tumours)","route":"/cancers/secondary-brain-tumours/"},{"id":"inflammatory-myofibroblastic-tumour","kind":"cancer","name":"Inflammatory myofibroblastic tumour (IMT)","route":"/cancers/inflammatory-myofibroblastic-tumour/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"paediatric-high-grade-glioma","kind":"cancer","name":"Paediatric high-grade glioma (excluding diffuse midline glioma)","route":"/cancers/paediatric-high-grade-glioma/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"company":[{"id":"chugai","kind":"company","name":"Chugai Pharmaceutical","route":"/companies/chugai/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct05170204","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small C","route":"/trials/nct05170204/"},{"id":"nct04774718","kind":"trial","name":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors","route":"/trials/nct04774718/"},{"id":"nct04302025","kind":"trial","name":"A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)","route":"/trials/nct04302025/"},{"id":"nct03178552","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)","route":"/trials/nct03178552/"},{"id":"alchemist","kind":"trial","name":"ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials)","route":"/trials/alchemist/"},{"id":"alesia","kind":"trial","name":"ALESIA","route":"/trials/alesia/"},{"id":"alex","kind":"trial","name":"ALEX","route":"/trials/alex/"},{"id":"alina","kind":"trial","name":"ALINA","route":"/trials/alina/"},{"id":"cupisco","kind":"trial","name":"CUPISCO","route":"/trials/cupisco/"},{"id":"nct05987644","kind":"trial","name":"Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements","route":"/trials/nct05987644/"},{"id":"determine-trial","kind":"trial","name":"DETERMINE","route":"/trials/determine-trial/"},{"id":"j-alex","kind":"trial","name":"J-ALEX","route":"/trials/j-alex/"},{"id":"mypathway","kind":"trial","name":"MyPathway","route":"/trials/mypathway/"},{"id":"nct06765109","kind":"trial","name":"Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","route":"/trials/nct06765109/"},{"id":"nct05987956","kind":"trial","name":"Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms","route":"/trials/nct05987956/"},{"id":"profile-1014","kind":"trial","name":"PROFILE 1014","route":"/trials/profile-1014/"},{"id":"nct05725200","kind":"trial","name":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer","route":"/trials/nct05725200/"},{"id":"nct04589845","kind":"trial","name":"Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study","route":"/trials/nct04589845/"}],"drug":[{"id":"neladalkib","kind":"drug","name":"Neladalkib","route":"/drugs/neladalkib/"}],"paper":[{"id":"paper-wu-alina-adjuvant-alectinib-nejm-2024","kind":"paper","name":"Alectinib in resected ALK-positive non-small-cell lung cancer","route":"/key-papers/paper-wu-alina-adjuvant-alectinib-nejm-2024/"},{"id":"paper-peters-alex-alectinib-crizotinib-nejm-2017","kind":"paper","name":"Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer","route":"/key-papers/paper-peters-alex-alectinib-crizotinib-nejm-2017/"},{"id":"paper-singhi-alk-rearrangements-pancreatic-jnccn-2017","kind":"paper","name":"Identification of targetable ALK rearrangements in pancreatic ductal adenocarcinoma","route":"/key-papers/paper-singhi-alk-rearrangements-pancreatic-jnccn-2017/"},{"id":"paper-gainor-alk-resistance-mutations-cancer-discov-2016","kind":"paper","name":"Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer","route":"/key-papers/paper-gainor-alk-resistance-mutations-cancer-discov-2016/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"}],"idea":[{"id":"idea-bio2-brain-met-prevention-trials","kind":"idea","name":"Prevention trials aimed only at brain metastasis","route":"/ideas/idea-bio2-brain-met-prevention-trials/"}],"pathway":[{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"},{"id":"blood-brain-barrier-metastasis","kind":"pathway","name":"The blood-brain barrier & brain metastasis","route":"/pathways/blood-brain-barrier-metastasis/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}