Annotation

Dabrafenib (TAFINLAR) is indicated for the treatment of unresectable or metastatic melanoma. Excerpts from the dabrafenib (TAFINLAR) product monograph:

TAFINLAR is indicated: as a monotherapy for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. In combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. A validated test is required to identify BRAF V600 mutation status. TAFLINAR should not be used in patients with BRAF wild-type melanoma.

Clinical data supporting the effectiveness of TAFINLAR monotherapy in patients with BRAF V600K mutations are limited, and clinical studies report fewer responses in BRAF V600K patients compared to BRAF V600E patients. There are no clinical data for TAFINLAR in the the treatment of patients with other less common BRAF V600 mutations.

The most commonly observed BRAF mutation, V600E, and the next most common, V600K, account for approximately 95% of BRAF mutations found in patients with melanoma. A number of less common substitutions include V600D, V600G and V600R.

For the complete product monograph text with sections containing pharmacogenetic information highlighted, see the dabrafenib product monograph.

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