Half of cancer drugs given accelerated approval fail in later trials

A recent study presented at the American Association for Cancer Research annual meeting revealed that about half of cancer drugs approved through the FDA’s accelerated approval pathway do not show improvement in patient survival or quality of life in subsequent clinical trials after five years. Despite this, the FDA has been converting accelerated approvals into full approvals with less stringent evidence of benefits. The study also found that drugs granted accelerated approval are spending less time in limbo before being pulled from the market if follow-up trials do not show a benefit, with the time dropping from 9.9 years in 2013 to 3.6 years in 2017.

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