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Pemazyre(pemigatinib)
Pemazyre (pemigatinib) is a small molecule pharmaceutical. Pemigatinib was first approved as Pemazyre on 2020-04-17. It is used to treat cholangiocarcinoma in the USA. It has been approved in Europe to treat cholangiocarcinoma. It is known to target fibroblast growth factor receptor 1, fibroblast growth factor receptor 3, and fibroblast growth factor receptor 2.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Pemazyre
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pemigatinib
Tradename
Company
Number
Date
Products
PEMAZYREIncyteN-213736 RX2020-04-17
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
pemazyreNew Drug Application2021-02-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cholangiocarcinoma—D018281C22.1
Agency Specific
FDA
EMA
Expiration
Code
PEMIGATINIB, PEMAZYRE, INCYTE CORP
2029-08-26ODE-404
2027-04-17ODE-292
2025-08-26I-899
2025-04-17NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Pemigatinib, Pemazyre, Incyte Corp
116281622040-08-30U-3568, U-3569, U-3570, U-3571
114660042039-05-03U-3464, U-3465, U-3466
96112672035-01-30DS, DP
101316672033-06-12U-2809
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EN: Fibroblast growth factor receptor (fgfr) tyrosine kinase inhibitors
— L01EN02: Pemigatinib
HCPCS
No data
Clinical
Clinical Trials
34 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
CholangiocarcinomaD018281C22.1241——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8036———8
Non-small-cell lung carcinomaD002289—4——15
Breast neoplasmsD001943EFO_0003869C5013———3
Gastrointestinal neoplasmsD005770C26.9—3———3
Endometrial neoplasmsD016889EFO_000423012———2
Colorectal neoplasmsD015179—2———2
Urologic neoplasmsD014571C64-C68—2———2
Stomach neoplasmsD013274EFO_0003897C1611———1
Lung neoplasmsD008175C34.9011———1
Multiple myelomaD009101C90.011———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePEMIGATINIB
INNpemigatinib
Description
Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21
Identifiers
PDB—
CAS-ID1513857-77-6
RxCUI—
ChEMBL IDCHEMBL4297522
ChEBI ID—
PubChem CID86705695
DrugBankDB15102
UNII IDY6BX7BL23K (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FGFR1
FGFR1
FGFR3
FGFR3
FGFR2
FGFR2
Organism
Homo sapiens
Gene name
FGFR1
Gene synonyms
BFGFR, CEK, FGFBR, FLG, FLT2, HBGFR
NCBI Gene ID
2260
Protein name
fibroblast growth factor receptor 1
Protein synonyms
Basic fibroblast growth factor receptor 1, bFGF-R-1, BFGFR, CD331, FGFR1/PLAG1 fusion, FLT-2, FMS-like tyrosine kinase 2, fms-related tyrosine kinase 2, heparin-binding growth factor receptor, hydroxyaryl-protein kinase, N-sam, Proto-oncogene c-Fgr
Uniprot ID
P11362
Mouse ortholog
Fgfr1 (14182)
fibroblast growth factor receptor 1 (P16092)
Variants
Clinical Variant
No data
Financial
Pemazyre - Incyte
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 752 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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21,527 adverse events reported
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