Advisory Board April 9, 2024

According to a new study published in JAMA, less than half of cancer drugs that received accelerated approval from FDA over the last decade have shown clinical benefit for patients.

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Study details and key findings

For the study, researchers examined data from 129 cancer drugs that were granted accelerated approval between 2013 and 2023.

Among 46 drugs that had been granted accelerated approval between 2013 and 2017, 29 drugs (63%) were ultimately converted to full FDA approval, while 10 (22%) were withdrawn. An additional seven drugs are still in ongoing trials, with a median follow-up of 6.3 years.

However, only 20 (43%) of the drugs granted accelerated approval demonstrated a clinical...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech, Survey / Study, Trends
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