Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved dabrafenib for reimbursement as a treatment option for the treatment of adults with unresectable or metastatic melanoma that harbor a BRAF V600 mutation.

This is written in the approval document as:

Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Citation

Dabrafenib Monotherapy, 2021, version number 5, NCCP National SACT Regimen, NCCP, viewed 08/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/melanoma/237dabrafenib.pdf

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