Annotation of U.S. Food and Drug Administration (FDA) label information
for cobimetinib
and BRAF
Summary
The FDA-approved drug label for cobimetinib (COTELLIC) states that it is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
Annotation
Excerpts from the cobimetinib drug label:
COTELLIC® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with COTELLIC with vemurafenib. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
The safety and efficacy of cobimetinib was established in a multicenter, randomized (1:1), double-blinded, placebo-controlled trial conducted in 495 patients with previously untreated, BRAF V600 mutation-positive, unresectable or metastatic, melanoma. The presence of BRAF V600 mutation was detected using the cobas® 4800 BRAF V600 mutation test.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the cobimetinib drug label.
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