Dabrafenib
B-Raf Serine-Threonine Kinase (Braf) Inhibitors
Sold as Finlee · TAFINLAR
- Drug class
- B-Raf Serine-Threonine Kinase (Braf) Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 11
Overview
Dabrafenib is an active pharmaceutical ingredient in the B-Raf Serine-Threonine Kinase (Braf) Inhibitors group (L01EC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | May 22, 2026 |
| CA Canada | Health Canada | 3 | March 20, 2026 |
| EU European Union | EMA | 2 | May 19, 2026 |
GBUnited Kingdom· MHRA
6 products
Uses
1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients 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 adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
How to take
CACanada· Health Canada
3 products
How to take
3 Pharmacokinetics). 6 Drug-Herb Interactions Interactions with herbal products have not been established. 7 Drug-Laboratory Test Interactions Interactions with laboratory tests have not been established. 1 Mechanism of Action TAFINLAR monotherapy: Dabrafenib is a selective, ATP-competitive small molecule inhibitor of RAF kinases, including BRAF.
Oncogenic amino acid variants in BRAF lead to constitutive activation of the mitogen-activated protein kinase (MAPK) pathway (including RAS/RAF/MEK/ERK) and may promote tumour cell growth. BRAF mutations have been identified in specific cancers, including approximately 50% of melanoma.
The most commonly observed BRAF mutation, V600E, and the next most common, V600K, account for approximately 95% of BRAF mutations found in patients with melanoma. A number of less common substitutions include V600D, V600G and V600R.
Tafinlar (dabrafenib) Page 49 of 106 Dabrafenib selectively inhibits BRAF V600E and other V600 mutations and with greater potency compared to wild-type BRAF in in vitro kinase inhibition assays. The concentration of dabrafenib required to inhibit 50% of enzyme activity (IC50) of each of the different BRAF proteins is shown in Table 21.
EUEuropean Union· EMA
2 products
Uses
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. 2).
How to take
Drug interactions
Known interactions involving Dabrafenib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 386. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB001011149 · revised May 22, 2026
- [2]Health Canada (DPD) · 02409607 · revised March 20, 2026
- [3]European Medicines Agency · EMEA/H/C/002604 · revised May 19, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.