Overall survival, progression-free survival and tumour response benefit supporting initial US FDA approval and indication extension of new cancer drugs, 2003-2021

J Clin Oncol

10 August 2022 - Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains uncertain. 

This study evaluates the clinical benefit supporting new cancer drugs' initial and supplemental U.S. FDA indication approval.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Regulation