Therapeutic Response

BRAF p.V600K status confers therapeutic sensitivity to Dabrafenib in combination with Trametinib in patients with Melanoma.

Statements

Source and description
Trametinib and Dabrafenib Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved trametinib in combination with dabrafenib for reimbursement as a treatment option for the treatment of adult patients with unresectable or metastatic melanoma that harbor a BRAF V600 mutation.
Trametinib and Dabrafenib Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved trametinib in combination with dabrafenib for reimbursement as a treatment option for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
Mekinist (trametinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Mekinist (trametinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
Tafinlar (dabrafenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized dabrafenib as a monotherapy or in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant.
Tafinlar (dabrafenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized dabrafenib in combination with trametinib for the adjuvant treatment of adult patients with stage 3 melanoma with a BRAF V600 variant, following complete resection.
Mekinist (trametinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized trametinib as a monotherapy or in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. Trametinib's product information further states that trametinib as a monotherapy has not demonstrated clinical activity in patients who have progressed on prior BRAF inhibitor therapy.
Mekinist (trametinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized trametinib as a monotherapy or in combination with dabrafenib for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 variant, following complete resection.
Tafinlar (dabrafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Tafinlar (dabrafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.