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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) BRAF p.V600E Melanoma Cobimetinib, Vemurafenib
HSE (1) BRAF p.V600K Melanoma Cobimetinib, Vemurafenib