MedPage Today March 26, 2025
— Longer time to full approval linked with safety concerns and lower clinical benefit
Key Takeaways
- A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent full approval.
- Nearly a quarter of cancer drugs granted accelerated approval demonstrated low clinical benefit at the time of full approval.
- Delayed confirmatory trials could be a cautionary signal for patients and their doctors considering these drugs, researchers said.
Among cancer drugs with accelerated approval, those backed with the...
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