[News] Study bolsters concerns about US FDA accelerated drug approvals

Half of the cancer drugs granted expedited approval by the US Food and Drug Administration (FDA) between 2013 and 2017 failed to show clinical benefits for patients in confirmatory trials more than 5 years later, according to a study by Liu and colleagues published in JAMA on April 7, 2024, and presented at the American Association of Cancer Research’s 2024 annual meeting. Of 39 confirmatory trials, 19 showed no overall survival or quality of life benefits for patients. Confirmatory studies had not yet been completed for seven other cancer drugs granted accelerated approval.