Drug · Small Molecule

Alectinib

CI-DRUG-00000047Explore in graph →NCIt C101790 CHEMBL1738797 CIViC Approved

Regulatory

Approvals (7)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-06-11 (see label)	approved	Jun 11, 2026	openfda
US FDA	—	Efficacy supplement 2024-04-18 (see label)	approved	Apr 18, 2024

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	25	14	12	50	7	CA, EU, US	Dec 11, 2015	Jun 20, 2013
Malignant Lung Neoplasm	Approved	Phase 4	11	5	6	25	2	EU, US	Dec 11, 2015	Jun 20, 2013
Non-Hodgkin Lymphoma	Phase3	Phase 3	2	2	1	2	0	—	—	Dec 18, 2023
Malignant Kidney Neoplasm	Phase3	Phase 3	1	1	1	1	0

Curated evidence

Clinical evidence (41)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–41 of 41 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ABCB1 Overexpression + ALK FusionALK ABCB11

Clinical trials

Trials with this intervention (61)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 61 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04302025	A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)(NAUTIKA1)	recruiting	Phase 2	99	Genentech, Inc.INDUSTRY	1	Sep 10, 2026	clinicaltrials
NCT06862869	Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

Molecule

Record

Kind: Small Molecule
Mechanism: ALK tyrosine kinase receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; EML4-ALK inhibitor
Targets: 3 genes
UNII: P9YY73LO6J
Aliases: 5H-benzo(b)carbazole-3-carbonitrile, 9-Ethyl-6,11-dihydro-6,6-dimethyl-8-(4-(4-morpholinyl)-1-piperidinyl)-11-oxo-, AF 802, AF-802, AF802, Alecensa, ALECENSA, ALECENSARO, Alectinib, ALECTINIB (CH5424802), ALECTINIBCH-5424802CH5424802CT-CH542, Alectinib Hydrochloride, ALECTINIB HYDROCHLORIDE, ALK Inhibitor RO5424802, CH 5424802, CH-5424802, CH5424802, RG 7853, RG7853, RG-7853,CH5424802, RO 5424802, RO-5424802, RO5424802

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01ED03	ALECTINIB
DIN (Health Canada)	02458136

ALK I11712
Alectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID1283 The I1171T mutation in ALK fusions was found in a NSCLC patient shown positive for ALK rearrangement via break apart FISH assay, who progressed after 8 months of crizotinib, and then progressed again … (full text at CIViC) PMID 25228534 · Katayama et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1367 A 51 year old female never-smoker was diagnosed with stage IV NSCLC with liver metastases. ALK rearrangement was verified via FISH. She was treated with crizotinib at 250 mg twice daily but discontinu… (full text at CIViC) PMID 25736571 · Ou et al., 2015 · Open in CIViC	civic

ALK I1171S + ALK Fusion2
Alectinib + CrizotinibSequential	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1484 Case study describes a caucasian male (age 38) never smoker presenting with stage IV non-small cell lung cancer with an ALK rearrangement. Patient was given crizotinib and exhibited a partial response… (full text at CIViC) PMID 25393796 · Ou et al., 2014 · Open in CIViC	civic
Alectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	2	submitted	EID12670 In an in vitro study, a FL5.12 cell line expressing EML4-ALK (known sensitizing alteration to crizotinib) and an ALK I1171S co-mutation, demonstrated increased resistance to alectinib treatment (IC50:… (full text at CIViC) PMID 27009859 · Amin et al., 2016 · Open in CIViC	civic

ALK L1196M + ALK Fusion2
Alectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID141 CH5424802 treatment resulted in significant tumor regression in xenograft models produced from Ba/F3 cells expressing EML4-ALK or EML4-ALK with the L1196M mutation. PMID 21575866 · Sakamoto et al., 2011 · Open in CIViC	civic
Alectinib + Brigatinib + Ceritinib + LorlatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	submitted	EID7597 Ba/F3 cells expressing EML4-ALK variant 1 (E13; A20) or variant 3 (E6a; A20) with the L1196M resistance mutation were sensitive to second and third generation ALK inhibitors. Cell viability assays sho… (full text at CIViC) PMID 29650534 · Yoda et al., 2018 · Open in CIViC	civic

ALK Fusion11
Alectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID1282 In this Phase II trial of 87 patients (NCT01871805), alectinib was assayed for safety and efficacy in ALK positive NSCLC that had progressed on crizotinib. Of 69 patients with measurable disease, 35 a… (full text at CIViC) PMID 26708155 · Shaw et al., 2016 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID7284 In a phase 3 trial, 303 patients with NSCLC with ALK fusion were randomly assigned to alectinib arm (N=152) or crizotinib arm (N=151). PFS was significantly longer with alectinib than with crizotinib … (full text at CIViC) PMID 28586279 · Peters et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	submitted	EID7533 In this phase II study the safety, efficacy, and pharmacokinetics of twice daily 600mg alectinib treatment was assessed in 138 patients with advanced NSCLC harboring ALK rearrangements (previously det… (full text at CIViC) PMID 26598747 · Ou et al., 2016 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	submitted	EID7872 National Comprehensive Cancer Network (NCCN) guidelines recommend alectinib for advanced ALK-positive NSCLC who are previously untreated or previously treated with crizotinib, including those with bra… (full text at CIViC) PMID 30030733 · Paik et al., 2018 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID8657 A randomized phase 3 trial (J-ALEX) of 207 Japanese ALK-positive NSCLC patients compared the efficacy and safety of alectinib (300mg twice daily) and crizotinib (250mg twice daily) in the first-line s… (full text at CIViC) PMID 28501140 · Hida et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID12012 In this global phase 3 trial, 257 patients with ALK-positive Non-Small-Cell Lung Cancer were treated with either alectinib (n = 130) or chemotherapy (n = 127). 93.8 % of the patients who had received … (full text at CIViC) PMID 38598794 · Wu et al., 2024 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1272 In this initial report of a single-arm Phase I and II study (JapicCTI-101264) of alectinib (CH5424802), 46 patients with advanced or metastatic ALK-rearranged non small cell lung cancer (NSCLC) were a… (full text at CIViC) PMID 23639470 · Seto et al., 2013 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1279 In this Phase I trial (NCT01588028) in 47 patients, alectinib was assessed for its effectiveness in treating locally advanced or metastatic ALK-positive NSCLC that had progressed or been resistant to … (full text at CIViC) PMID 25153538 · Gadgeel et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1273 In this case study of a critically ill 29 year old male nonsmoker with advanced metastatic ALK-positive NSCLC, alectinib (CH5424802), was administered as first line treatment. Where most clinical tria… (full text at CIViC) PMID 26938871 · Yoshida et al., 2016 · Open in CIViC	civic
Alectinib + CrizotinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID4858 In a randomized, open-label phase 3 trial 303 patients with ALK-positive, previously untreated NSCLC (including asympt. CNS disease) were randomized to reiceive either Alectinib or Crizotinib. During … (full text at CIViC) PMID 28586279 · Peters et al., 2017 · Open in CIViC	civic
Alectinib + Crizotinib + EntrectinibSubstitutes	Gastrointestinal CarcinomaUNRESOLVED	Predictive	C	Supports Sensitivity Response	3	submitted	EID10324 Retrospective analysis of patients with ALK-fusion positive gastrointestinal cancers. 13 patients were identified (5 pancreas, 3 right-sided colon, 1 gastric, 1 duodenal, 1 rectal, 1 left-sided colon,… (full text at CIViC) PMID 35476549 · Ambrosini et al., 2022 · Open in CIViC	civic