Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Vemurafenib in patients with Melanoma.

Statements

Source and description
Zelboraf (vemurafenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Vemurafenib's product information states the special warning and caution that the efficacy and safety of vemurafenib in patients with tumors expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established.
Vemurafenib Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved vemurafenib for reimbursement as a monotherapy treatment option for the treatment of adult patients with unresectable or metastatic melanoma whose tumors are BRAF V600 positive.
Zelboraf (vemurafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.