Inside Precision Medicine April 10, 2024
More than half of cancer drugs granted accelerated approval between 2013 and 2017 did not demonstrate a significant improvement in overall survival (OS) or quality of life (QoL) within five years of approval, shows an analysis of U.S. Food and Drug Administration (FDA) data.
The study by postdoctoral research fellow Ian Liu and colleagues at Brigham and Women’s Hospital and Harvard Medical School also found that approvals for conversion from accelerated to regular approval were typically granted based on surrogate outcome measures, such as response rates or progression-free survival (PFS), rather than those showing clear clinical benefit like OS.
This can leave patients and clinicians with “uncertainty as to the drug’s actual benefit, especially after such a long period of...
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