Product Description
Dacomitinib is a multi-kinase receptor inhibitor used in the therapy of cases of non-small cell lung cancer that harbor activating mutations in the epidermal growth factor receptor gene (EGFR). Dacomitinib is associated with high rate of transient serum aminotransferase elevations during therapy but has not been linked to instances of clinically apparent acute liver injury. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Dacomitinib)
Mechanisms of Action: TK Inhibitor,EGFR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Austria | Bangladesh | Belgium | Canada | Chile | Colombia | Croatia | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Oncology Unspecified
Known Adverse Events: Alopecia | Stomatitis | Pruritus | Paronychia | Diarrhea
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Hong Kong, Italy, Japan, Korea, Malaysia, Poland, Singapore, South Korea, Spain, Thailand
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer
Phase 2: Head and Neck Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ATORG-003 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-03-31 |
|
| STCC-01 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer|Head and Neck Cancer|Squamous Cell Carcinoma |
2025-07-01 |
|
| A randomized, non-comparative, phase II study investigating the best epidermal growth factor recept | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2023-11-20 |
|
| CTR20132928 | P3 |
Completed |
Non-Small-Cell Lung Cancer |
2022-01-27 |