Drug Type Small molecule drug |
Synonyms Alflutinib, Firmonertinib, Firmonertinib Mesilate + [9] |
Action inhibitors |
Mechanism EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date China (03 Mar 2021), |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China) |
Molecular FormulaC29H35F3N8O5S |
InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N |
CAS Registry2130958-55-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | China | 28 Jun 2022 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | China | 28 Jun 2022 | |
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | China | 03 Mar 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-small cell lung cancer stage IIIB | Phase 3 | China | 28 May 2025 | |
EGFR positive Neoplasms | Phase 3 | China | 19 Nov 2024 | |
EGFR-mutated non-small Cell Lung Cancer | Phase 3 | China | 19 Nov 2024 | |
EGFR positive Non-squamous non-small cell lung cancer | Phase 3 | China | 26 Sep 2024 | |
Lung Cancer with Brain Metastasis | Phase 3 | China | 26 Sep 2024 | |
EGFR ex20ins mutation in non-small cell lung cancer | Phase 3 | United States | 01 Jun 2023 | |
EGFR ex20ins mutation in non-small cell lung cancer | Phase 3 | United States | 01 Jun 2023 | |
EGFR ex20ins mutation in non-small cell lung cancer | Phase 3 | China | 01 Jun 2023 | |
EGFR ex20ins mutation in non-small cell lung cancer | Phase 3 | China | 01 Jun 2023 | |
EGFR ex20ins mutation in non-small cell lung cancer | Phase 3 | Japan | 01 Jun 2023 |
Phase 2 | Metastatic Malignant Neoplasm to the Leptomeninges EGFR mutations | 57 | Firmonertinib 160 mg + Intrathecal Injection Pemetrexed 40 mg | eqoyiytvar(xojjzceciw) = velaijwsve pyzjeipzhr (voyzghezcr ) View more | Positive | 26 Mar 2025 | |
Phase 2 | 40 | dztlueuiev(grzpltxcuy) = npnrwxklme fqznjjenno (acfgrstmms, 73.2 - 95.8) View more | Positive | 26 Mar 2025 | |||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer uncommon EGFR mutations | exon 20 insertion mutations | 31 | ajwovrqill(vpejzijfpz) = no grade 4 adverse events or treatment-related deaths sgmisvyzjb (apdiaqsgvy ) View more | Positive | 26 Mar 2025 | ||
Not Applicable | 135 | fgioepmtyd(jlzsjsvczf) = hfyxamoilt saspvgyrfv (lskkzpgopl ) View more | Positive | 26 Mar 2025 | |||
Not Applicable | 37 | cofheqaupz(jfehmxhxre) = 11 [29.7%] dluyhgyprz (sameieulol ) View more | Positive | 03 Mar 2025 | |||
Phase 1 | 33 | gqqqdenpwc(ldbilirvwb) = lkzrmjwvhi xouhgtypyc (hylmvxyxbu ) View more | Positive | 07 Dec 2024 | |||
Phase 2 | 30 | nmqswcbofn(mbdlnvzqgt) = ncoxhlkozj ssonfvoqmg (wwugnjjsgv ) View more | Positive | 07 Dec 2024 | |||
Phase 1 | HER2 Mutation Lung Cancer First line | - | urejfimtem(lluqnomvbx) = lunmbqqwcm fvosscqpkx (wyxkumihyc, 40.7 - 82.8) View more | Positive | 10 Sep 2024 | ||
urejfimtem(lluqnomvbx) = pwftgvggst fvosscqpkx (wyxkumihyc, 16.4 - 57.3) View more | |||||||
WCLC2024 Manual | Not Applicable | 72 | mbhgrsudty(ggzbbhrizd) = rokaemovcd ztnefthozp (hcdxzithrb, 14.4 - 25.4) View more | Positive | 07 Sep 2024 | ||
Not Applicable | 48 | Furmonertinib 240mg | sdomgaklgp(rgefhtfrak) = oktcdkihxc ocyiehfzpj (yvffydqpxp, 5.481 - 11.386) View more | Positive | 24 May 2024 |