Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized dabrafenib as a monotherapy or in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant.
This is written in the approval document as:
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Citation
Novartis Europharm Limited. Tafinlar (dabrafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf. Revised March 2024. Accessed March 23, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRAF p.V600E | Melanoma | Dabrafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Dabrafenib | |
| Sensitivity (+) | BRAF p.V600E | Melanoma | Dabrafenib, Trametinib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Dabrafenib, Trametinib |