Drug · Small Molecule

Tucatinib

CI-DRUG-00000615Explore in graph →NCIt C77896 CHEMBL3989868 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.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2023-01-19 (see label)	approved	Jan 19, 2023	openfda
US FDA	HER2-Positive Breast Carcinoma	in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.	approved	Apr 17, 2020	openfda
US FDA	—	This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.accelerated	approved	Apr 17, 2020	openfda
US FDA	Malignant Colorectal Neoplasm

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 16 hours 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	33	13	6	51	7	CA, EU, US	Apr 17, 2020	Dec 31, 2013
Malignant Breast Neoplasm	Approved	Phase 4	21	8	4	32	2	EU, US	Apr 17, 2020	Feb 28, 2014
Malignant Lung Neoplasm	Phase4	Phase 4	3	0	0	3	0	—	—	Jan 11, 2021
Malignant Cervical Neoplasm	Phase4	Phase 4	1	0	0	1	0

Curated evidence

Clinical evidence (2)

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

civicCuratedShowing 1–2 of 2 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
ERBB2 Amplification1
Capecitabine + Trastuzumab

Clinical trials

Trials with this intervention (55)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–55 of 55 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
NCT04512261	TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases(TOPAZ)	withdrawn	Phase 1 / Phase 2	0	Reva BashoOTHER	1	Jul 1, 2022	clinicaltrials
NCT03846583	Tucatinib + Abemaciclib + Herceptin for HER2+ MBC	withdrawn

Molecule

Record

Kind: Small Molecule
Mechanism: Receptor protein-tyrosine kinase erbB-2 inhibitor
Targets: 1 gene
UNII: 234248D0HH
Aliases: ARRY 380, ARRY-380, ARRY380, Irbinitinib, MK-7119, N6-(4,4-Dimethyl-4,5-dihydrooxazol-2-yl)-N4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine, ONT 380, ONT-380, ONT380, Tucatinib, Tukysa

Data updated 19 hours agoSource updated unknown

Identifiers

Codes (6)

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

System	Code	Label
ATC (WHO)	L01EH03	TUCATINIB
DIN (Health Canada)	02499827	TUKYSA
DIN (Health Canada)