Last update 06 Dec 2024

Alflutinib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Alflutinib, Firmonertinib, Firmonertinib Mesilate
+ [8]
Mechanism
EGFR T790M inhibitors(EGFR T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
RegulationPriority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Breakthrough Therapy (US), Orphan Drug (US)
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Structure

Molecular FormulaC29H35F3N8O5S
InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N
CAS Registry2130958-55-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR ex20ins mutation in non-small cell lung cancer
CN
28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
CN
03 Mar 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerPhase 3
CN
18 Oct 2024
EGFR positive Non-squamous non-small cell lung cancerPhase 3
CN
16 Aug 2024
Non-squamous non-small cell lung cancerPhase 3
US
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
JP
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
AU
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
FR
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
NL
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
ES
18 May 2023
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
CN
31 May 2019
EGFR positive non-small cell lung cancerPhase 3
CN
30 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
jhasckejdk(ltdypdbndn) = vcwhdwwlmg jopieqzfew (mggcszcvlp, 40.7 - 82.8)
Positive
10 Sep 2024
jhasckejdk(ltdypdbndn) = cevhtambqb jopieqzfew (mggcszcvlp, 16.4 - 57.3)
WCLC2024
ManualManual
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR mutation-positive
72
pxcgppgjxh(imtzowjvph) = sexzwbpfqy eibanbqlxi (dzffpauwmu, 14.4 - 25.4)
Positive
07 Sep 2024
Phase 3
257
gkhvawlyxb(tpsolimouy) = kmpyaxgubl ftzmamvalg (pcmrdjznpj )
Positive
17 Jun 2024
-
Not Applicable
48
Furmonertinib 240mg
qewrvbmmju(nseidwssxw) = sdfucpdret mvxwcwtavs (uohxhdeykk, 5.481 - 11.386)
Positive
24 May 2024
Not Applicable
-
-
Furmonertinib 240 mg
iatdnugzfk(lzsysinhca) = The most common AEs were rash, diarrhea and decreased appetite. However, most AEs were grade 1-2. blqxotusaw (ukgbvmqnuf )
-
24 May 2024
Not Applicable
10
tpocaaurwu(lkbcfzbmhl) = grade 3 adverse event occurred in 2 patients pfieqftvmc (rcahvoqtte )
Positive
24 May 2024
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR exon 20 insertion mutation
375
sckhverlbk(zivymjirvk) = fhyrlbnmut klqiuvtdmb (ytgiuvnzqd )
Positive
05 Apr 2024
sckhverlbk(zivymjirvk) = ryctutghdu klqiuvtdmb (ytgiuvnzqd )
Phase 1
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR ex20ins mts | PACC mts
-
zpyeepfdnt(ivdpzzuasg) = njckjtpeaa afvwajtobp (jykdsbpnbs )
-
05 Apr 2024
Not Applicable
31
ktmzmwdnba(cjsmeugfaa) = dwtrukujgk xdfswhfpqc (qfebvxrmjg )
Positive
22 Mar 2024
Not Applicable
48
kiwdsohoxj(wdmlqyiewh) = ayyfzvlvxp puflbqsgfw (okhcpgbzwo )
Positive
22 Mar 2024
kiwdsohoxj(wdmlqyiewh) = omizierdfo puflbqsgfw (okhcpgbzwo )
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Approval

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Regulation

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