Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved cobimetinib in combination with vemurafenib for reimbursement as a treatment option for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF p.V600 mutation, as demonstrated by a validated test method.

This is written in the approval document as:

Cobimetinib and vemurafenib in combination are indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Citation

Cobimetinib and Vemurafenib Therapy, 2020, version number 2, NCCP National SACT Regimen, NCCP, viewed 19/12/2023, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/melanoma/cobimetinib%20and%20vemurafenib%20therapy.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 Cobimetinib, Vemurafenib
Sensitivity (+) BRAF p.V600K Melanoma Cobimetinib, Vemurafenib