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) [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.
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.
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.