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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
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 Application2020-04-17
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-3510
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
53 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_0003869C5010172——24
Colorectal neoplasmsD015179331——5
AdenocarcinomaD000230141——4
Invasive hydatidiform moleD002820D39.2111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8013———4
Brain neoplasmsD001932EFO_0003833C7123———4
Non-hodgkin lymphomaD008228C85.9—2———2
Multiple myelomaD009101C90.0—2———2
Non-small-cell lung carcinomaD00228912———2
Renal cell carcinomaD002292—2———2
Rectal neoplasmsD012004—2———2
CholangiocarcinomaD018281C22.111———1
Gallbladder neoplasmsD005706EFO_0004606C2311———1
Triple negative breast neoplasmsD064726—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Drug interactionsD0043472————2
Hepatic insufficiencyD0485501————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)
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
Clinical Variant
No data
Financial
Tukysa - Seagen Inc.
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 916 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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95 adverse events reported
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