Therapeutic Response

BRAF p.V600K status confers therapeutic sensitivity to Cobimetinib in combination with Vemurafenib in patients with Melanoma.

Statements

Source and description
Cotellic (cobimetinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized cobimetinib in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF p.V600 variant.
Cotellic (cobimetinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to cobimetinib in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Cobimetinib and Vemurafenib Therapy. NCCP National SACT Regimen. HSE. 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.