Drug Type Small molecule drug |
Synonyms Dacomitinib (USAN), Dacomitinib anhydrous, Dacomitinib Hydrate + [11] |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (27 Sep 2018), |
RegulationOrphan Drug (US), Priority Review (CN), Special Review Project (CN) |
Molecular FormulaC24H27ClFN5O3 |
InChIKeyBSPLGGCPNTZPIH-IPZCTEOASA-N |
CAS Registry1042385-75-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10514 | Dacomitinib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | KR | 14 Feb 2020 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | KR | 14 Feb 2020 | |
Locally Advanced Lung Non-Small Cell Carcinoma | KR | 14 Feb 2020 | |
Non-Small Cell Lung Cancer | CN | 15 May 2019 | |
EGFR-mutated non-small Cell Lung Cancer | EU | 02 Apr 2019 | |
EGFR-mutated non-small Cell Lung Cancer | IS | 02 Apr 2019 | |
EGFR-mutated non-small Cell Lung Cancer | LI | 02 Apr 2019 | |
EGFR-mutated non-small Cell Lung Cancer | NO | 02 Apr 2019 | |
EGFR positive non-small cell lung cancer | JP | 08 Jan 2019 | |
metastatic non-small cell lung cancer | US | 27 Sep 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | US | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | CN | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | JP | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | AT | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | BE | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | DK | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | FI | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | FR | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | DE | 16 Jun 2011 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | GR | 16 Jun 2011 |
Phase 4 | 101 | imivfzeygq(ujqtembiuv) = nzwzwbmron dcvdluydug (tcgeklzxae, gncvoyowmy - vrkmhgsntm) View more | - | 05 Apr 2024 | |||
Phase 2 | 14 | Dacomitinib 45mg | pdrlwivhuh(mdoekatgbw) = 8/14; 57.1% myvoyyzxrk (gwknbjbrrd ) View more | Positive | 02 Dec 2023 | ||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer First line epidermal growth factor receptor (EGFR) 21L858R mutation | 155 | First-line dacomitinib | gvxztjlflb(ktfevkacus) = ylhrbbjrbb inzwrfrlwp (qwsmphxgkp, 13.7 - 18.9) View more | Positive | 02 Dec 2023 | |
Not Applicable | 16 | oyypjvrxdr(jkdihuhima) = qstsfdjvws eqxvtryiun (zrqubdhlbv, 4.32 - 23.7) View more | Positive | 02 Dec 2023 | |||
Not Applicable | 87 | iqwwhvykhs(hnpbkdrbha) = pzwugwcyer gqmmcllomo (fttfpvogux ) View more | Positive | 02 Dec 2023 | |||
Phase 3 | 153 | rcxdbhgrfe(vgmhgkqctf) = brjftfvckm qldkykasht (fytenjawbh ) View more | Positive | 02 Dec 2023 | |||
Not Applicable | 111 | gqtdovgquh(iewopidmzk) = vvozmgxhny pevmlxhcjp (rcbvqyfqou ) View more | - | 23 Oct 2023 | |||
gqtdovgquh(iewopidmzk) = vtsajbydlf pevmlxhcjp (rcbvqyfqou ) View more | |||||||
Phase 3 | 300 | jcnlhqwouh(abuqtxiimt) = enbvsfqlvv vgntwllyhi (tulaxigfrp ) | Positive | 23 Oct 2023 | |||
AFANDA (ASCO2023) Manual | Not Applicable | 133 | (Common mutations) | kqhxurhejg(qjkorkjblu) = izqluhmhhn rlkzagufuw (gvgoaxzrhw ) View more | Positive | 31 May 2023 | |
(Common mutation plus uncommon mutations) | kqhxurhejg(qjkorkjblu) = sajogqzxpy rlkzagufuw (gvgoaxzrhw ) View more | ||||||
Phase 2 | EGFR-mutated non-small Cell Lung Cancer EGFR mutated | 24 | avgzfgqcnl(tlgwksiqqr) = fqkirmnjza scvoyajmwf (ajkqmsedba ) View more | Positive | 03 Dec 2022 |