Mutation to Medicine

Improved Survival with Vemurafenib in Melanoma

Hensin Tsao, MD, PhD

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This landmark study may well prompt FDA activity. Wider access to vemurafenib would enlarge the melanoma medicine cabinet for late-stage disease. Despite the excitement, several points are worth noting: First, follow-up in the interim analysis was short, so longer-term data are needed. Second, for the many patients without BRAF V600E mutations, immunologic treatments and targets further downstream (e.g., MEK) may be an answer, but truly personalized medicine depends on having options for every genotype. Additionally, even some patients with BRAF V600E mutations will not respond, so markers of likely response would be beneficial. Most importantly, many patients with an initial response soon relapse: Vemurafenib delivers a concussive but not a lethal blow. Studies of vemurafenib resistance mechanisms have been published, and the pipeline for future analysis is open. If approved, vemurafenib will become the first-choice drug for many, but unmet needs will leave us all wanting more than the drug can deliver.

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