Indicated for unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA.
Not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.
2 mg orally once daily, to be taken at least 1 hour before or 2 hours after a meal.
Duration of therapy: Until disease progression or unacceptable toxicity occurs.
As a single agent, overall response rate 54% with a median duration of response of 5.6 months for metastatic melanoma.
In combination with dabrafenib, overall response rate 76% with a median duration of response of 10.5 months in metastatic melanoma.