Tafinlar is a cancer medicine used to treat people whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600’. It is used: - in adults and adolescents aged 12 years and older for the treatment of melanoma (a skin cancer) that has spread or cannot be removed surgically. Tafinlar is used on its own or in combination with another cancer medicine, trametinib; - in adults and adolescents aged 12 years and older for the treatment of advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib; - in adults for the treatment of advanced non-small cell lung cancer. It is used in combination with trametinib; - in adults for the treatment of differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. Tafinlar is used in combination with trametinib when the cancer has progressed or spread locally or to other parts of the body during or after previous treatment with systemic therapy (treatment affecting the whole body), and does not respond to or is not suitable for treatment with radioactive iodine. Tafinlar contains the active substance dabrafenib.
Therapeutic Indication
### Therapeutic indication **Melanoma** Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). **Adjuvant treatment of melanoma** Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. **Non-small cell lung cancer (NSCLC)** Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. **Differentiated thyroid cancer (DTC)** Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).
Therapeutic Area (MeSH)
ATC Code
L01EC02
ATC Item
dabrafenib
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| dabrafenib mesilate | N/A | 达拉非尼 |
EMA Name
Tafinlar
Medicine Name
Tafinlar
Aliases
N/A
