Last update 18 May 2024

Gefitinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-(3'-chloro-4'-fluoroanilino)-7-methoxy-6-(3-morpholinopropoxy)quinazoline, Gefitinib (JAN/USAN/INN), N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-(4-morpholinyl)propoxy)-4-quinazolinamine
+ [7]
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Orphan Drug (US)
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Structure

Molecular FormulaC22H24ClFN4O3
InChIKeyXGALLCVXEZPNRQ-UHFFFAOYSA-N
CAS Registry184475-35-2

External Link

KEGGWikiATCDrug Bank
D01977Gefitinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Locally Advanced Lung Non-Small Cell Carcinoma
EU
24 Jun 2009
Locally Advanced Lung Non-Small Cell Carcinoma
IS
24 Jun 2009
Locally Advanced Lung Non-Small Cell Carcinoma
LI
24 Jun 2009
Locally Advanced Lung Non-Small Cell Carcinoma
NO
24 Jun 2009
metastatic non-small cell lung cancer
EU
24 Jun 2009
metastatic non-small cell lung cancer
IS
24 Jun 2009
metastatic non-small cell lung cancer
LI
24 Jun 2009
metastatic non-small cell lung cancer
NO
24 Jun 2009
Non-Small Cell Lung Cancer
US
05 May 2003
EGFR-mutated non-small Cell Lung Cancer
JP
05 Jul 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-squamous non-small cell lung cancerPhase 3
DE
01 Nov 2015
EGFR positive non-small cell lung cancerPhase 3
CN
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
JP
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
FR
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
DE
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
HK
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
HU
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
IT
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
RU
15 Mar 2012
EGFR positive non-small cell lung cancerPhase 3
KR
15 Mar 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ESMO2023
ManualManual
Not Applicable
80
smajewthzk(lrcpncrzkc) = vlevesmdyj etzhratnlw (gfdhejextv )
Positive
23 Oct 2023
smajewthzk(lrcpncrzkc) = jewxpprznb etzhratnlw (gfdhejextv )
Not Applicable
806
zioztyqoek(aibctksqnz) = yvbsgwzarb xdpjzwygyp (crqekmniby, 0.54 - 0.72)
Positive
31 May 2023
Not Applicable
30
ijsxtcgkdw(nhjyoywhkl) = gidpoxnwuo uqcjjodhyt (zkgvbnxhcj )
Positive
06 Mar 2023
Not Applicable
510
wvcszudeaj(ixnvfxycwk) = doanhjaqfn nmnnoocuge (cgcpldamsv )
-
21 Sep 2022
wvcszudeaj(ixnvfxycwk) = kovtvzyvgp nmnnoocuge (cgcpldamsv )
Not Applicable
27
yodlgftbtk(rxrrjofcov) = jqwpmcqidt dojtwwavcm (jrshnxsylb )
-
21 Sep 2022
Not Applicable
468
pqdhhiggnv(olcqockpam) = rnohdcjvxk unjudryuub (vjvxluofcs, 26.24 - 34.36)
-
21 Sep 2022
Not Applicable
Non-Small Cell Lung Cancer
First line
EGFRm | EGFR p.T790M
51
ibxoflheei(cncnmgcvzm) = shioetfbez lsacqtnpwm (kjywuiytcw, 4.5 - 35.6)
Positive
04 Sep 2022
ibxoflheei(cncnmgcvzm) = iladgzqzsq lsacqtnpwm (kjywuiytcw, 1.8 - 17.5)
Phase 3
345
beqmiknqbs(mvbnzzrwkd) = pqyoplusde bmijqwjgrr (uykjogauqm, 41.8 ~ 56.7)
Superior
12 Aug 2022
beqmiknqbs(mvbnzzrwkd) = pqmflmznrn bmijqwjgrr (uykjogauqm, 31.1 ~ 47.1)
Not Applicable
-
8
abdzlgczeq(ujrpjzhibl) = EGFR-TKI plus antiangiogenic agents failed to show a statistically significant improvement in the OS compared to erlotinib alone wfdnbmyesd (dikokehivd )
-
06 Aug 2022
Not Applicable
205
nnmufsfenk(svsfqigryj) = uiypfnarvf wvtlxaeisy (voqavzqfij )
-
06 Aug 2022
nnmufsfenk(svsfqigryj) = vvafrvjfck wvtlxaeisy (voqavzqfij )
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Regulation

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