Newswire (Published: Thursday, November 15, 2018, 2:50:00 AM CST, Received: Thursday, November 15, 2018, 4:30:44 AM CST)

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The US Food and Drug Administration (FDA) issued draft guidance on Tuesday to aid sponsors in using metastasis-free survival (MFS) as a clinical trial endpoint for developing drugs or biologic products indicated for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related to the interpretation of trial results and to the analyses of MFS described in the agencys new four-page draft guidance document.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.

A large magnitude of treatment effect on MFS with an acceptable safety profile could be used to demonstrate clinical benefit and support product approval, FDAs Oncologic Drugs Advisory Committee concluded in 2011.

The guidance features considerations for general trial design, imaging, how to interpret trial results and analyzing MFS.


Earlier this year, Janssens Erleada (apalutamide) became the first FDA-approved treatment for patients diagnosed with nonmetastatic castration-resistant prostate cancer. The Erleada approval was touted as the first to use the MFS endpoint. The agency is committed to fostering the development of novel therapies, FDA Commissioner Scott Gottlieb said Tuesday. Not only can these endpoints be a predictor of overall survival, but they can be critical to showing an investigational drug is effective.


US Food and Drug Administration




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