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Braftovi(encorafenib)
Braftovi (encorafenib) is a small molecule pharmaceutical. Encorafenib was first approved as Braftovi on 2018-06-27. It is used to treat melanoma in the USA. It has been approved in Europe to treat colorectal neoplasms and melanoma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
Trade Name
FDA
EMA
Braftovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Encorafenib
Tradename
Company
Number
Date
Products
BRAFTOVIArray BiopharmaN-210496 RX2018-06-27
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
braftoviNew Drug Application2022-06-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
melanoma—D008545—
Agency Specific
FDA
EMA
Expiration
Code
ENCORAFENIB, BRAFTOVI, ARRAY BIOPHARMA INC
2025-06-27ODE-194
2023-06-27NCE
2023-04-08I-826
Patent Expiration
Patent
Expires
Flag
FDA Information
Encorafenib, Braftovi, Array Biopharma Inc
94747542033-08-05U-2802
93872082032-11-21DP
97639412032-11-21U-2335
102586222032-11-21U-2802
93144642031-07-04U-2336, U-2802, U-2803
85017582030-08-27DS, DP
95930992030-08-27DP
95931002030-08-27DP
98502292030-08-27U-2337
98502302030-08-27U-2334, U-2802, U-2803
100057612030-08-27U-2335, U-2802, U-2803
85415752030-02-26DS, DPU-2335, U-2802, U-2803
89462502029-07-23DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EC: B-raf serine-threonine kinase (braf) inhibitors
— L01EC03: Encorafenib
HCPCS
No data
Clinical
Clinical Trials
75 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C806811116
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854511183—332
Colorectal neoplasmsD0151797102—117
AdenocarcinomaD000230231——4
Colonic neoplasmsD003110C18121——3
Biliary tract neoplasmsD001661C24.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228945———8
Brain neoplasmsD001932EFO_0003833C7113———4
Renal cell carcinomaD00229222———3
Thyroid neoplasmsD013964EFO_000384111———2
Rectal neoplasmsD01200411———2
Neoplasm metastasisD009362EFO_000970811———1
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
Hairy cell leukemiaD007943C91.4—1———1
GlioblastomaD005909EFO_0000515—1———1
GliosarcomaD018316—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD0485501————1
Skin neoplasmsD012878EFO_0004198C441————1
GliomaD005910EFO_00005201————1
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameENCORAFENIB
INNencorafenib
Description
Encorafenib, sold under the brand name Braftovi, is a medication for the treatment of certain melanoma cancers. It is a small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway. This pathway occurs in many different cancers including melanoma and colorectal cancers. The substance was being developed by Novartis and then by Array BioPharma. In June 2018, it was approved by the FDA in combination with binimetinib for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.
Classification
Small molecule
Drug classrapidly accelerated fibrosarcoma (RAF) kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COC(=O)N[C@@H](C)CNc1nccc(-c2cn(C(C)C)nc2-c2cc(Cl)cc(NS(C)(=O)=O)c2F)n1
Identifiers
PDB—
CAS-ID1269440-17-6
RxCUI2049106
ChEMBL IDCHEMBL3301612
ChEBI ID—
PubChem CID50922675
DrugBankDB11718
UNII ID8L7891MRB6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Braftovi - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,040 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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62,500 adverse events reported
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