The FDA has demonstrated a willingness to expedite access to new cancer medicines by using real-world evidence to support regulatory drug approval. In this article, we explore three recent examples of such approvals and the lessons that can be learned from this collective experience.
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The work of C.M.B. is supported as the Canada Research Chair in population Cancer Care.
The authors declare no competing interests.
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Raphael, M.J., Gyawali, B. & Booth, C.M. Real-world evidence and regulatory drug approval. Nat Rev Clin Oncol 17, 271–272 (2020). https://doi.org/10.1038/s41571-020-0345-7
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