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Tabrecta(capmatinib)
Tabrecta (capmatinib) is a small molecule pharmaceutical. Capmatinib was first approved as Tabrecta on 2020-05-06. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against hepatocyte growth factor receptor.
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FDA Novel Drug Approvals 2020
Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Tabrecta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Capmatinib hydrochloride
Tradename
Company
Number
Date
Products
TABRECTANovartisN-213591 RX2020-05-06
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tabrectaNew Drug Application2020-05-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
CAPMATINIB HYDROCHLORIDE, TABRECTA, NOVARTIS PHARM
2027-05-06ODE-291
2025-05-06NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Capmatinib Hydrochloride, Tabrecta, Novartis Pharm
105961782035-07-22DS, DP
84206452031-06-05DS, DP
89011232029-05-20U-2813
77676752027-11-19DS, DP
84613302027-11-19DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX17: Capmatinib
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228951421525
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8063———9
Lung neoplasmsD008175C34.9012———3
MelanomaD008545—2———2
Liver neoplasmsD008113EFO_1001513C22.012———2
Squamous cell carcinomaD002294—1———1
Invasive hydatidiform moleD002820D39.2—1———1
Kidney neoplasmsD007680EFO_0003865C64—1———1
Hepatocellular carcinomaD006528C22.0—1———1
AdenocarcinomaD000230—1———1
Breast neoplasmsD001943EFO_0003869C5011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD0151792————2
Renal cell carcinomaD0022921————1
GlioblastomaD005909EFO_00005151————1
GliosarcomaD0183161————1
Triple negative breast neoplasmsD0647261————1
Hepatic insufficiencyD0485501————1
Squamous cell carcinoma of head and neckD0000771951————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCAPMATINIB
INNcapmatinib
Description
Capmatinib, sold under the brand name Tabrecta, is an anticancer medication used for the treatment of metastatic non-small cell lung cancer whose tumors have a mutation that leads to the exon 14 skipping of the MET gene, which codes for the membrane receptor HGFR.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1ccc(-c2cnc3ncc(Cc4ccc5ncccc5c4)n3n2)cc1F
Identifiers
PDB—
CAS-ID1029712-80-8
RxCUI—
ChEMBL IDCHEMBL3188267
ChEBI ID—
PubChem CID25145656
DrugBankDB11791
UNII IDTY34L4F9OZ (ChemIDplus, GSRS)
Target
Agency Approved
MET
MET
Organism
Homo sapiens
Gene name
MET
Gene synonyms
NCBI Gene ID
4233
Protein name
hepatocyte growth factor receptor
Protein synonyms
HGF receptor, HGF/SF receptor, Proto-oncogene c-Met, Scatter factor receptor, SF receptor, Tyrosine-protein kinase Met
Uniprot ID
Q9UPL8
Mouse ortholog
Met (17295)
hepatocyte growth factor receptor (P16056)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tabrecta - Incyte
$
€
£
₣
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Tabrecta - Novartis
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 983 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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499 adverse events reported
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