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

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.