Product Description
Osimertinib is used to help prevent a certain type of non small-cell lung cancer (NSCLC) from returning after the tumor(s) has been removed by surgery in adults. It is also used as a first treatment for a certain type of NSCLC that has spread to other parts of the body in adults. Osimertinib is also used to treat certain types of NSCLC that has spread to other parts of the body in adults who could not be treated successfully with other similar chemotherapy medications. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. (Sourced from: https://medlineplus.gov/druginfo/meds/a616005.html)
Mechanisms of Action: EGFR Inhibitor,TK Inhibitor,ERBB2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Lung CancerPriority Review - Lung Cancer *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Oncology Unspecified
Known Adverse Events: Diarrhea
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 116
Highest Development Phases
Phase 3: Lung Cancer|Non-Small-Cell Lung Cancer|Oncology Unspecified|Small Cell Lung Cancer|Squamous Cell Carcinoma
Phase 2: Adenocarcinoma|Bladder Cancer|Brain Cancer|Bronchial Cancer|Bronchogenic Carcinoma|Cervical Cancer|Colorectal Cancer|Esophageal Cancer|Esophageal Diseases|Gastrointestinal Cancer|Glioblastoma|Intestinal Diseases|Meningeal Cancer|Ovarian Cancer|Ovarian Diseases|Pancreatic Cancer|Rectal Diseases|Respiratory Tract Cancer|Skin Cancer|Thoracic Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031210628 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer |
2032-12-31 |
|
| D516FC00001(ADAURA2) | P3 |
Unknown Status |
Non-Small-Cell Lung Cancer |
2032-11-01 |
|
| D516NC00001 | P3 |
Unknown Status |
Non-Small-Cell Lung Cancer |
2032-05-26 |
|
| ADAURA2 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2032-03-22 |