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The Magnitude Matters: GSK Approvals Show How To Use PFS After Other Drugs Show Survival

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Submitting an NDA based on progression-free survival when other drugs for the indication have been approved on the basis of overall survival benefits is a risky proposition, but GlaxoSmithKline was confident the magnitude of Mekinist and Tafinlar’s PFS effect in metastatic melanoma would make the findings clinically relevant.

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