Fierce Pharma April 8, 2024
One hallmark of the FDA’s accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. Now, new research shows that many cancer drugs approved under the pathway couldn’t demonstrate survival benefits after five years.
The FDA’s accelerated approval pathway dates back to 1992, when it was first used to quickly roll out treatments to address the HIV/AIDS epidemic of the 1980s.
These days, more than 80% of all accelerated approvals are granted for oncology therapies, according to a recent study published in the Journal of the American Medical Association.
For the recent study, the team looked at the clinical benefits of certain oncology meds that secured accelerated approval and their subsequent performance in confirmatory studies.
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