Drugs / DACOMITINIB ANHYDROUS
DACOMITINIB ANHYDROUS
also known as
Dacomitinib · PF-00299804 · PF-299804 · Dacomitinib hydrate · Dacomitinib monohydrate · PF-00299804-03 · Vizimpro
Small molecule targets CYP2D6, EGFR, ERBB2, ERBB4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed lung cancer 2 milestones | |||||
| Filed | EU (EMA) | — | lung cancer | 2018-04-04 | “The European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.” pfizer.com ↗ |
| Filed | US (FDA) | — | lung cancer | 2018-04-04 | “the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted priority review for dacomitinib” pfizer.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Vizimpro | — | 2019-04-02 | europa.eu ↗ |
| Approved | US (FDA) | VIZIMPRO | — | 2018-09-27 | fda.gov ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03755102 | Nov 2018 → Jul 2023 | lung cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 120 trials | ||||||
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03865446 | Apr → Oct 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03810807 | Jan 2019 → Dec 2025 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02097433 | Jul → Sep 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01920061 | Sep 2013 → Jan 2020 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01918761 | Jul 2013 → Sep 2016 | non-small cell lung carcinoma | Central European Cooperative Oncology Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01796327 | Apr → Jun 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01737008 | Jan 2013 → Feb 2015 | head and neck squamous cell carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT01702506 | Oct 2012 → Jan 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01571388 | Apr → Aug 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01441128 | Sep 2011 → Feb 2014 | adenocarcinoma, large cell carcinoma, non-small cell lung carcinoma, squamous cell carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01318031 | Mar → Jun 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01121575 | Aug 2010 → Feb 2014 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00971191 | Feb 2010 → Apr 2012 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01034748 | Jan → Feb 2010 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00999817 | Nov → Dec 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00728390 | Dec 2008 → Aug 2011 | metastatic neoplasm, non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00783328 | Nov 2008 → Mar 2011 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00728468 | Sep 2008 → Apr 2011 | cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00225121 | Oct 2005 → Apr 2007 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05271916 | Oct 2022 → Jan 2025 overdue | non-small cell lung carcinoma | Shanghai Chest Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02039336 | Apr 2014 → Aug 2018 | colorectal cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT01116843 | May 2010 → Feb 2012 | oral cavity cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 223 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT04946968 | Aug 2021 → Apr 2027 expected | head and neck squamous cell carcinoma, non-small cell lung carcinoma | National Cancer Centre, Singapore | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04504071 | Dec 2020 → Dec 2022 overdue | non-small cell lung carcinoma | Shanghai Chest Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04675008 | Dec 2020 → Sep 2022 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT04423185 | Aug 2020 → Jul 2026 overdue | — | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT04339829 | Aug 2020 → Jul 2022 | — | Guangdong Association of Clinical Trials | Unknown | No outcome recorded |
| Phase 2 | NCT04811001 | Jun 2020 → Dec 2023 | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Unknown | No outcome recorded |
| Phase 2 | NCT04027647 | Sep 2019 → Mar 2026 overdue | non-small cell lung carcinoma | National Cancer Centre, Singapore | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02382796 | Jul 2015 → May 2019 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02268747 | Nov 2014 → Nov 2016 | skin squamous cell carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | No outcome recorded |
| Phase 2 | NCT02047747 | Feb 2014 → Feb 2016 | brain cancer | David Piccioni, M.D., Ph.D | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01858389 | Jul 2013 → Sep 2015 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01728233 | Jun 2013 → Sep 2018 | penile neoplasm, squamous cell carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT01520870 | Feb 2012 → Apr 2015 | brain cancer, glioblastoma | Grupo Español de Investigación en Neurooncología | Completed | No outcome recorded |
| Phase 2 | NCT01465802 | Dec 2011 → May 2015 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01449201 | Oct 2011 → Oct 2013 | head and neck squamous cell carcinoma | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT01152853 | Jul 2010 → Jul 2011 | gastric cancer | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01112527 | Apr 2010 → Sep 2015 | glioblastoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00818441 | Mar 2009 → Apr 2012 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 2 | NCT00768664 | Nov 2008 → May 2010 | head and neck neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00769067 | Nov 2008 → Oct 2010 | non-small cell lung carcinoma | Pfizer | Completed | Met primary |
| Phase 2 | NCT00548093 | Apr 2008 → Mar 2010 | non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00553254 | Feb 2008 → Aug 2010 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT01774721 | May 2013 → Jul 2016 | lung cancer | Pfizer | Completed | Met primary |
| Phase 3 | NCT01360554 | Jun 2011 → Sep 2013 | non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04511533 | Aug 2020 → Oct 2022 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01484847 | Dec 2011 → Mar 2013 | head and neck squamous cell carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT06486142 Comparator | Sep 2022 → Sep 2028 expected | non-small cell lung carcinoma | Region Skane | Recruiting | No outcome recorded |
| Phase 3 | NCT01000025 Comparator | Dec 2009 → Jan 2014 | lung cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-06-03 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic of Four Drugs for the Treatment of Non-Small Cell Lung Cancer and Malignant Melanoma chugai-pharm.co.jp ↗
for non-small cell lung cancer (NSCLC) therapies, a tyrosine kinase inhibitor VIZIMPRO ® tablets (generic name: dacomitinib hydrate) |
| 2019-04-03 | Pfizer | Regulatory VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO ® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. |
| 2019-02-01 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations pfizer.com ↗
Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. |
| 2018-09-27 | Pfizer | Regulatory U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2018-06-04 | Pfizer | Results Dacomitinib Shows More than Seven-Month Improvement in Overall Survival Compared to an Established Therapy in Advanced NSCLC with EGFR-Activating Mutations pfizer.com ↗
The trial showed a median OS of 34.1 months for patients receiving dacomitinib (95% CI: 29.5, 37.7), representing a more than seven-month improvement compared to 26.8 months with gefitinib (95% CI: 23.7, 32.1). |
| 2018-04-04 | Pfizer | Regulatory U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations pfizer.com ↗
The European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication. |
All press releases naming this drug 6 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DACOMITINIB ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110732 ↗ |
| Known as | Dacomitinib | “Dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor ([HER]-1/EGFR, HER-2, and HER-4) tyrosine kinase inhibitor, demonstrated antitumor...” PMID 25521398 ↗ Oct 201437“A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung...” PMID 24501009 ↗ Feb 2014 “Dacomitinib, an irreversible panHER inhibitor, shows significant preclinical antitumor activity in human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC).” PMID 26581547 ↗ Nov 2015 “Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial.” PMID 25439692 ↗ Oct 2014 “Dacomitinib (PF-00299804) is an oral, irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases.” PMID 22249430 ↗ Jan 2012 |
| Known as | Dacomitinib hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110732 ↗ |
| Known as | Dacomitinib monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110732 ↗ |
| Known as | PF-00299804 | “Dacomitinib (PF-00299804) is a small-molecule inhibitor of the tyrosine kinases human epidermal growth factor receptor-1 (HER1; epidermal growth factor receptor, EGFR), HER2,...” PMID 26048096 ↗ Jun 201526“Dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor ([HER]-1/EGFR, HER-2, and HER-4) tyrosine kinase inhibitor, demonstrated antitumor...” PMID 25521398 ↗ Oct 2014 “A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung...” PMID 24501009 ↗ Feb 2014 “This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet...” NCT01796327 ↗ “Dacomitinib (PF-00299804, Vizimpro) was developed as a second-generation, oral, irreversible inhibitor of human epidermal growth factor receptor (EGFR)- 1, -2 and -4 tyrosine kinase.” PMID 31050691 ↗ Apr 2019 “Dacomitinib (PF-00299804) is an oral, irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases.” PMID 22249430 ↗ Jan 2012 “Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)” NCT01702506 ↗ “A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer” NCT01858389 ↗ “Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing” NCT01360554 ↗ “Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing” NCT00818441 ↗ “Dacomitinib (PF-00299804, Pfizer) is a second-generation, irreversible EGFRTKI” NCT04811001 ↗ |
| Known as | PF-00299804-03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110732 ↗ |
| Known as | PF-299804 | “PF299804 is a potent, orally available, irreversible inhibitor of tyrosine kinase human epidermal growth factor receptors (HER) 1 (EGFR), HER2, and HER4.” PMID 21220471 ↗ Jan 20111“PF-299804 (Dacomitinib)” NCT01520870 ↗ |
| Known as | Vizimpro | “Dacomitinib (PF-00299804, Vizimpro) was developed as a second-generation, oral, irreversible inhibitor of human epidermal growth factor receptor (EGFR)- 1, -2 and -4 tyrosine kinase.” PMID 31050691 ↗ Apr 2019 |
| Action | Inhibit | “PF299804 is a potent, orally available, irreversible inhibitor of tyrosine kinase human epidermal growth factor receptors (HER) 1 (EGFR), HER2, and HER4.” PMID 21220471 ↗ Jan 20112“Receptor protein-tyrosine kinase erbB-2 inhibitor” CHEMBL2110732 ↗ “Receptor protein-tyrosine kinase erbB-4 inhibitor” CHEMBL2110732 ↗ |
| Modality | Small molecule | “Dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor ([HER]-1/EGFR, HER-2, and HER-4) tyrosine kinase inhibitor” PMID 25521398 ↗ Oct 2014 |
| Route | Oral | “investigational drug by oral route” NCT00225121 ↗ |
| Target | EGFR | “PF299804 is a potent, orally available, irreversible inhibitor of tyrosine kinase human epidermal growth factor receptors (HER) 1 (EGFR), HER2, and HER4.” PMID 21220471 ↗ Jan 2011 |
| Target | ERBB2 | “Receptor protein-tyrosine kinase erbB-2 inhibitor” CHEMBL2110732 ↗ |
| Target | ERBB4 | “Receptor protein-tyrosine kinase erbB-4 inhibitor” CHEMBL2110732 ↗ |