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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
The United States Food and Drug Administration (FDA) has classified Olaparib (brand name Lynparza) as a Breakthrough Therapy for men with metastatic castrate-resistant prostate cancer with DNA repair defects in their tumours. This means the application to have Olaparib approved by the FDA for prostate cancer will be fast tracked and it is likely that Olaparib will be approved later this year. The FDA's decision to recognise Olaparib as a Breakthrough Therapy was reported in ONCLive
Orteronel (TAK-700) is an androgen synthesis inhibitor. It selectively inhibits the enzyme CYP17A1.. A paper presented yesterday at the American Society for Clinical Oncology (ASCO) meeting reported the results of a second large Phase III clinical trial of Orteronel + Prednisone in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer. In the trial, whilst treatment with Orteronel + Prednisone was shown to delay the onset of radiographic progression, there was no overall survival benefit. Orteronel + Prednisone was also associated with a number of significant side effects compared to placebo + prednisone; 30% of patients on the Orteronel + Prednisone arm of the trial discontinued due to adverse side effects. A previous Phase III clinical trial of Ortoronel + Prednisone for the treatment of men with progressive, metastatic, castration-resistant prostate cancer who had been previously treated with at least one cycle of docetaxel-based chemotherapy also showed no overall survival benefit. The New Prostate Cancer Infolink commented: "This is clearly a second major setback for the potential of Orteronel as a potential treatment for prostate cancer, and it is hard to see that the developers will pursue the potential of this product for much longer.” Given that other drugs recently approved by the American Food and Drug Administration (FDA) such as Zytiga and Xtandi have demonstrated an overall survival benefit, it is unlikely that Orteronel would receive FDA approval on the current evidence.