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AboutPricing
Drug ReportsTucatinib
Tukysa(tucatinib)
Tukysa (tucatinib) is a small molecule pharmaceutical. Tucatinib was first approved as Tukysa on 2020-04-17. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms and neoplasm metastasis. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2. In addition, it is known to target epidermal growth factor receptor and receptor tyrosine-protein kinase erbB-4.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Tukysa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tucatinib
Tradename
Company
Number
Date
Products
TUKYSASeagenN-213411 RX2020-04-17
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tukysaNew Drug Application2024-11-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
Expiration
Code
TUCATINIB, TUKYSA, SEAGEN
2030-01-19ODE-422
2027-04-17ODE-309
2026-01-19I-906
2025-04-17NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tucatinib, Tukysa, Seagen
112073242038-04-27U-3783
116665722038-04-27U-3783
115043702033-03-25U-2788
94570932032-10-12DPU-2788
86480872031-04-12DS, DP
96939892027-05-09DPU-2788
74528952024-11-16DS, DPU-2788
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EH: Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors
— L01EH03: Tucatinib
HCPCS
No data
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5016273—240
Colorectal neoplasmsD015179——341——6
AdenocarcinomaD000230——251——6
CarcinomaD002277—C80.0421——5
Esophageal neoplasmsD004938—C15111——2
Invasive hydatidiform moleD002820—D39.2111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8036———8
Neoplasm metastasisD009362EFO_0009708—35———7
Brain neoplasmsD001932EFO_0003833C7134———6
Triple negative breast neoplasmsD064726——22———3
Non-small-cell lung carcinomaD002289——22———3
Stomach neoplasmsD013274EFO_0003897C1623———3
Non-hodgkin lymphomaD008228—C85.9—2———2
Multiple myelomaD009101—C90.0—2———2
Colonic neoplasmsD003110—C18—2———2
Renal cell carcinomaD002292EFO_0000376——2———2
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Drug interactionsD004347——2————2
Hepatic insufficiencyD048550——1————1
Lung neoplasmsD008175HP_0100526C34.901————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTucatinib
INNtucatinib
Description
Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics (formerly Oncothyreon, subsequently part of Seattle Genetics).
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cc(Nc2ncnc3ccc(NC4=NC(C)(C)CO4)cc23)ccc1Oc1ccn2ncnc2c1
Identifiers
PDB—
CAS-ID937263-43-9
RxCUI—
ChEMBL IDCHEMBL3989868
ChEBI ID—
PubChem CID51039094
DrugBankDB11652
UNII ID234248D0HH (ChemIDplus, GSRS)
Target
Agency Approved
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
2064
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
P04626
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Alternate
EGFR
EGFR
ERBB4
ERBB4
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Tukysa – Seagen
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Tukysa – Pfizer
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,562 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,038 adverse events reported
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