Earlier this year, two drugs (apalutamide/Erleada and enzalutamide/Xtandi) were each approved for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC) based on the use of metastasis-free survival (MFS) as the study endpoint in clinical trials. … READ MORE …
Filed under: Drugs in development | Tagged: endpoint, metastasis-free, MFS, survival, trial | Leave a comment »
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: approval, castration-resistant, indication, metastasis-free, non-metastatic, survival | 2 Comments »
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: enpoint, metastasis-free, overall, surrogate, survival, trial | 2 Comments »
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 …
Filed under: Drugs in development, Management, Treatment | Tagged: endpoint, kinetics, metastasis-free, PSA, survival | Leave a comment »
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