Overview
Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains. Dacomitinib was developed by Pfizer Inc and approved by the FDA on September 27, 2018. Some evidence in the literature suggests the therapeutic potential of dacomitinib in the epithelial ovarian cancer model, although further investigations are needed.
Indication
Dacomitinib is indicated as the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as verified by an FDA-approved test. Lung cancer is the leading cause of cancer death and NSCLC accounts for 85% of lung cancer cases. From the cases of NSCLC, approximately 75% of the patients present a late diagnosis with metastatic and advanced disease which produces a survival rate of 5%. The presence of a mutation in EGFR accounts for more than the 60% of the NSCLC cases and the overexpression of EGFR is associated with frequent lymph node metastasis and poor chemosensitivity.
Associated Conditions
- Metastatic Non-Small Cell Lung Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/28 | N/A | Completed | |||
2022/03/09 | Phase 1 | Recruiting | |||
2021/07/01 | Phase 2 | Active, not recruiting | National Cancer Centre, Singapore | ||
2021/03/23 | Phase 2 | Recruiting | Fondazione Ricerca Traslazionale | ||
2021/02/24 | N/A | Recruiting | Peking Union Medical College | ||
2021/01/22 | N/A | Recruiting | |||
2020/12/19 | Phase 2 | UNKNOWN | |||
2020/10/30 | N/A | Completed | |||
2020/10/05 | N/A | UNKNOWN | |||
2020/08/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 0069-2299 | ORAL | 45 mg in 1 1 | 12/1/2020 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0197 | ORAL | 15 mg in 1 1 | 12/1/2020 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1198 | ORAL | 30 mg in 1 1 | 12/1/2020 | |
| U.S. Pharmaceuticals | 63539-197 | ORAL | 15 mg in 1 1 | 12/23/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VIZIMPRO FILM-COATED TABLET 45MG | SIN15965P | TABLET, FILM COATED | 45 mg | 6/25/2020 | |
| VIZIMPRO FILM-COATED TABLET 30MG | SIN15967P | TABLET, FILM COATED | 30 mg | 6/25/2020 | |
| VIZIMPRO FILM-COATED TABLET 15MG | SIN15966P | TABLET, FILM COATED | 15 mg | 6/25/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dacomitinib Tablets | 国药准字HJ20190036 | 化学药品 | 片剂 | 2/29/2024 | |
| Dacomitinib Tablets | 国药准字H20234140 | 化学药品 | 片剂 | 12/18/2023 | |
| Dacomitinib Tablets | 国药准字HJ20190037 | 化学药品 | 片剂 | 2/29/2024 | |
| Dacomitinib Tablets | 国药准字H20234139 | 化学药品 | 片剂 | 12/18/2023 | |
| Dacomitinib Tablets | 国药准字H20254253 | 化学药品 | 片剂 | 5/27/2025 | |
| Dacomitinib Tablets | 国药准字H20254223 | 化学药品 | 片剂 | 5/20/2025 | |
| Dacomitinib Tablets | 国药准字H20254254 | 化学药品 | 片剂 | 5/27/2025 | |
| Dacomitinib Tablets | 国药准字H20254268 | 化学药品 | 片剂 | 5/27/2025 | |
| Dacomitinib Tablets | 国药准字H20254222 | 化学药品 | 片剂 | 5/20/2025 | |
| Dacomitinib Tablets | 国药准字H20254264 | 化学药品 | 片剂 | 5/27/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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