MFS as a new endpoint in prostate cancer drug development

An article by staff at the U.S. Food and Drug Administration (FDA) in this week’s New England Journal of Medicine (NEJM) addresses the use of metastasis-free survival (MFS) as the primary endpoint in the trial that led to approval of apalutamide (Erleada) earlier this year. … READ MORE …

Metastasis-free survival as a surrogate endpoint in prostate cancer clinical trials

As many readers will have realized, the major regulatory authorities started, some time ago, to accept prostate cancer progression-free survival of differing types as a surrogate for overall survival in the approval of some drugs for the treatment of prostate cancer. … READ MORE …

Are changes in PSA kinetics potentially indicative of metastasis-free survival?

Researchers at Johns Hopkins have provided data to support the hypothesis that, in men being treated with novel, non-hormonal agents for non-metastatic, non-castrate, biochemically recurrent prostate cancer after first-line therapy, changes in PSA kinetics may be indicative of metastasis-free survival. … READ MORE …