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FDA Considers Toxicity Profiles As Meeting Unmet Need In Melanoma

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline’s Mekinist (trametinib) and Tafinlar (dabrafenib) qualified for the regulatory benefits afforded drugs that address unmet medical needs under a broad theory introduced in FDA’s draft guidance on expedited approval pathways: offering different, but not necessarily better, toxicity profiles than marketed drugs was seen as an advantage.

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