Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA

Cancer Network

10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for clinical trials focused on patients with non-metastatic castration resistant prostate cancer which expanded on some of the recommendations that were made 3 years after the release of the draft for comment.

In addition to including editorial changes for clarity, the guidance also had recommendations for sponsors on aspects such as general trial design, imaging, and considerations for interpreting data from the trial and metastasis-free survival analyses.

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Michael Wonder

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Michael Wonder