Product Description
Dabrafenib is used alone or in combination with trametinib (Mekinist) to treat a certain types of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. It is also used along with trametinib to treat and prevent the return of a certain type of melanoma after surgery to remove it and any affected lymph nodes. Dabrafenib is also used in combination with trametinib to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. It is also used to treat a certain type of thyroid cancer that has spread to nearby tissues or to other parts of the body that has not responded to previous treatment(s). Dabrafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a613038.html)
Mechanisms of Action: BRAF Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Latvia | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: Lung Cancer | Melanoma | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Thyroid Cancer | Oncology Unspecified
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Alopecia | Dermatitis | Keratosis | Paronychia | Arthralgia | Myalgia | Melanoma | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Papilloma | Oncology Unspecified | Dyspnea | Chills | Constipation | Diarrhea | Edema
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: BeiGene
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Melanoma|Oncology Unspecified|Thyroid Cancer
Phase 2: Adamantinoma|Craniopharyngioma|Glioma|Non-Small-Cell Lung Cancer
Phase 1: Multiple Myeloma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Swecranio | P2 |
Recruiting |
Craniopharyngioma|Adamantinoma |
2027-09-10 |
|
| CDRB436J12301 | P3 |
Active, not recruiting |
Thyroid Cancer |
2027-05-06 |
|
| MCC-20-MEL-11-PMC | P1 |
Recruiting |
Melanoma |
2026-12-31 |
|
| CDRB436ECN01 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2024-11-21 |