Posted on June 28, 2018 by Sitemaster
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 »
Posted on November 16, 2012 by Sitemaster
According to a summary statement of opinion issued yesterday by the Committee for Medicinal Products for Human Use (CMPH) of the European Mediciens Agency (EMEA), CMPH is recommending an expanded indication for the clinical use of abiraterone acetate in men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized | Tagged: abiraterone, Europe, indication, Zytiga | 4 Comments »