The assay is indicated to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants and may benefit from FDA-approved targeted therapies.
Accelerated approval is based on objective response rate and duration of response in advanced melanoma, with postapproval trials required to confirm clinical benefit.
A real‐world Brazilian registry suggests that challenges in biologic distribution were associated with treatment interruption, particularly among therapies requiring more frequent dosing.
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