Product Description
Entrectinib is used to treat metastatic (lung cancer that has already spread) non-small cell lung cancer (NSCLC) that is caused by a gene called ROS1. This medicine is also used to treat solid tumors (cancer) that are caused by certain abnormal NTRK genes and have spread or if surgery to remove the cancer is likely to cause severe complications, and there is no acceptable treatment option or the cancer grew or spread on other treatments. Entrectinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed. (Sourced from: https://www.mayoclinic.org/drugs-supplements/entrectinib-oral-route/side-effects/drg-20470004?p=1)
Mechanisms of Action: ALK Inhibitor,TRKA Antagonist,TRKB Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Ecuador | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | 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: Dizziness | Dysgeusia | Vision Disorders | Arthralgia | Myalgia | Dyspnea | Constipation | Diarrhea | Edema
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Korea, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 12
Highest Development Phases
Phase 3: Brain Cancer|Glioma|Lymphoproliferative Disorders|Melanoma|Non-Small-Cell Lung Cancer
Phase 2: Breast Cancer|Fibrosarcoma|Medulloblastoma|Nephroma, Mesoblastic|Neuroblastoma|Oncology Solid Tumor Unspecified|Salivary Gland Cancer|Sarcoma, Ewing|Thyroid Cancer|Wilms Tumor
Phase 1: Acute Myeloid Leukemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-001155-39 | P2 |
Unknown status |
Brain Cancer |
2030-12-22 |
|
| DETERMINE | P3 |
Recruiting |
Brain Cancer|Lymphoproliferative Disorders|Glioma|Melanoma |
2029-10-01 |
|
| 2019-003859-11 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2028-07-03 |
|
| MO41552 | P3 |
Unknown Status |
Non-Small-Cell Lung Cancer |
2027-12-01 |