Last update 17 Dec 2024

Erdafitinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Erdafitinib (USAN/INN), 890E37NHMV, G-024
+ [5]
Mechanism
FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Orphan Drug (KR), Breakthrough Therapy (US)
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Structure

Molecular FormulaC25H30N6O2
InChIKeyOLAHOMJCDNXHFI-UHFFFAOYSA-N
CAS Registry1346242-81-6

External Link

KEGGWikiATCDrug Bank
D10927Erdafitinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic urothelial carcinoma
EU
22 Aug 2024
Metastatic urothelial carcinoma
IS
22 Aug 2024
Metastatic urothelial carcinoma
LI
22 Aug 2024
Metastatic urothelial carcinoma
NO
22 Aug 2024
Unresectable Urothelial Carcinoma
EU
22 Aug 2024
Unresectable Urothelial Carcinoma
IS
22 Aug 2024
Unresectable Urothelial Carcinoma
LI
22 Aug 2024
Unresectable Urothelial Carcinoma
NO
22 Aug 2024
FGFR2 positive Transitional Cell Carcinoma
KR
24 Nov 2022
FGFR3 positive Transitional Cell Carcinoma
KR
24 Nov 2022
Bladder Cancer
CA
09 Dec 2019
Transitional Cell Carcinoma
CA
25 Oct 2019
FGFR positive Transitional Cell Carcinoma
US
12 Apr 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Urothelial CarcinomaNDA/BLA
CN
15 Dec 2023
Advanced Urothelial CarcinomaNDA/BLA
CN
15 Dec 2023
Advanced Urothelial CarcinomaNDA/BLA
CN
15 Dec 2023
Non-Muscle Invasive Bladder NeoplasmsPhase 3
US
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
CN
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
JP
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
AR
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
AT
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
BE
18 Apr 2024
Non-Muscle Invasive Bladder NeoplasmsPhase 3
BR
18 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
20
Computed Tomography+Erdafitinib
peqehtlcqp(vobwcmnewp) = xsszmzydbq lzdraoozhy (zftnohdyyi, nulgsvnyjd - dcoyoueidw)
-
19 Sep 2024
Not Applicable
-
jxuispcoxv(gxlegeyfye) = gytttfdfdc cvlhikoptz (fpijfvyoaw )
-
15 Sep 2024
Not Applicable
Metastatic urothelial carcinoma
FGFR2/3-altered | MTAP loss
633
gxaqphhhwn(kxpxobrghg) = efairermgj scriofnpgm (nhsyhfrbgv )
Positive
24 May 2024
Phase 2
FGFR1-4 mutations or fusions
-
nlvgwcuwfj(xkkmhatdpt) = qdetxrhosp xcbmfjmlki (rqmiuuxgky, 5.7 - 33.0)
Positive
01 Apr 2024
Phase 2
FGFR1-4 amplification
-
ugmksvqkhi(drhegtexoj) = There were no confirmed responses to erdafitinib; however, five patients experienced stable disease (SD) as best response asivoaarvy (dzwrvonfhn )
Negative
01 Apr 2024
Phase 1
178
leeeokfqvq(hwqwpzsdzq) = rbayeqeozv kbdohjvwui (ipubtihncj )
Positive
25 Jan 2024
Not Applicable
94
dhxvekdlvn(bfbdalhfii) = mfgiqrbcnz ptxhyuaiez (myloxdulww )
Positive
25 Jan 2024
dhxvekdlvn(bfbdalhfii) = roilxhzchp ptxhyuaiez (myloxdulww )
Phase 2
-
-
tfokiglsld(gcwrvzvrrr) = izgqmrzeec rzpblqqxgi (bpgrzidazy, 30.8 - 78.5)
Positive
23 Oct 2023
Phase 1
43
qqvvdljsxf(qwdubnxyva) = erceauhchh krezxaexrs (bhokaxsaqz )
Positive
22 Oct 2023
(Cohort 1)
wnwhgwrrkf(hzbmprdkde) = uevyvoewhf xufdahncmo (owjkphyuko, 2.96 - NE)
Phase 2
217
zjcmwyyuzm(svkoquuyxl) = ajwrnldibw uvnibcovkv (qwfwwrqakd, 24 - 36)
-
01 Aug 2023
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