Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Cobimetinib, Vemurafenib in patients with Melanoma.
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 statement is based on a regulatory approval from the Health Service Executive:
Cobimetinib and vemurafenib in combination are indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.