From 2009 to 2022, the FDA approved 65 malignant hematology and oncology treatments under the Accelerated Approval (AA) program. After approval, these drugs must show clinical benefits (such as longer progression-free survival or overall survival). However, since 2009, 15 (23%) of these approvals have been withdrawn due to a lack of demonstrated benefit.
In this study, researchers calculated the percentage of patients exposed to oncology drugs later withdrawn due to a lack of confirmed benefit following AA approval.
Why this matters
With the growing number of cancer therapies being granted AA and the increasing number of FDA withdrawals due to negative post-approval trials, it is crucial to strike a balance between providing timely access to cancer therapies and maintaining high standards of safety and efficacy for patients.