USA – FDA Drafts Guidance on Using Metastasis-Free Survival Endpoints in Prostate Cancer Posted 13 November 2018 | By Ana Mulero

The US Food and Drug Administration (FDA) issued draft guidance on Tuesday to aid sponsors in using metastasis-free survival (MFS) as a clinical trial endpoint for developing drugs or biologic products indicated for treatment of nonmetastatic castration-resistant prostate cancer.

Sponsors are encouraged to design clinical trials that use MFS as an endpoint based on the general design and imaging considerations as well as considerations related to the interpretation of trial results and to the analyses of MFS described in the agency’s new four-page draft guidance document.

The new recommendations seek to tackle issues around the prolonged assessment period for patients with nonmetastatic castration-resistant prostate cancer rendering the “use of overall survival impractical as a primary endpoint to support approval of products in this disease setting,” FDA said…