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Jim Marshall (not a doctor) said ... In the USA the Food and Drug Administration (FDA) decides which drugs have enough evidence of effectiveness for the company to sell. In the USA Insurance companies then decide whether to pay for the treatment. (In Australia the TGA approves, the PBAC decides whether it is worth spending public money on, then the drug goes on the PBS.) Note this drug is not approved on the basis that it will make you live longer. Its approval is because it delays the appearance of new lots of cancer (mets, or metastases). As the study carries on, we may learn about its effect on survival sometime in the future. ... end Jim From the FDA press release: The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. The following link to the FDA press release may not last forever: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596768.htm