Annotation

The FDA-approved drug label for dabrafenib (TAFINLAR) notes that mutations in the BRAF gene, such as those that result in the V600E mutation, may lead to constitutively activated BRAF kinases that stimulate tumor cell growth. TAFINLAR inhibits BRAF V600 mutation-positive melanoma cell growth, both in vivo and in vitro. However, the label also notes that BRAF inhibitors such as TAFINLAR may lead to increased cell proliferation in BRAF wild-type cells, so confirmation of BRAF V600E or V600K mutation status is necessary prior to administration of the drug.

Excerpts from the dabrafenib (TAFINLAR) drug label:

TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

TAFINLAR is indicated, 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 is not indicated for treatment of patients with wild-type BRAF melanoma.

Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.

Permanently discontinue TAFINLAR in patients who develop RAS mutation-positive non-cutaneous malignancies.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the dabrafenib drug label.

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