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.

Historically, FDA has declined to approve cancer drugs based on progression-free survival when earlier agents for the same disease had already been approved on the gold-standard endpoint of overall survival – but recent targeted therapy approvals suggest the agency is becoming more open to doing just that.

In those situations – as GlaxoSmithKline PLC’s Tafinlar (dabrafenib) and Mekinist (trametinib) and Boehringer Ingelheim Pharmaceuticals Inc.’sGilotrif (afatinib) showed...

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