The FDA Accelerated Approval pathway, which has been pivotal in enabling early access to new oncology drugs over the past three decades, has recently come under increased scrutiny. New draft guidance published in March 2023 offers several possible solutions to improve this pathway, with the ultimate goal of improving outcomes for patients with cancer, but might also have important limitations.
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Food and Drug Omnibus Reform Act: https://www.thefdalawblog.com/wp-content/uploads/2023/01/HPM-FDORA-Summary-and-Analysis.pdf
Project Confirm: https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm
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Benjamin, D.J., Lythgoe, M.P. The FDA’s latest draft guidance on accelerated approvals — one step forward, two steps back?. Nat Rev Clin Oncol 20, 577–578 (2023). https://doi.org/10.1038/s41571-023-00788-5
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DOI: https://doi.org/10.1038/s41571-023-00788-5
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