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  1. 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
  2. Apalutamide (JNJ-56021927 formerly known as ARN 509) is a novel small-molecule androgen receptor antagonist similar to enzalutamide but with less central nervous system penetration, which could potentially result in reduced levels of fatigue and seizures. Curetoday.com has an article about 2 Phase 3 clinical trials of Apalutamide: the ATLAS trial (NCT02531516; learn more here); the SPARTAN study (NCT01946204; learn more here). The SPARTAN study is currently recruiting in Australia; the ATLAS study is not. For SPARTAN, eligible patients must show no signs of evident metastatic prostate cancer and must have a high risk for disease progression. A high risk for disease progression is defined as either a PSA doubling time (PSADT) of less than 10 months while on continuous ADT, or Castrate Resistant Prostate cancer demonstrated while on continuous ADT. PSADT is calculated using at least three PSA values during ADT.
  3. "It is clear from these data that apalutamide has activity in the treatment of men with nmCRPC. This is not a surprise. However, the degree of promise for apalutamide based on these data (compared to other drugs already available on the market) is much harder to evaluate. Would treatment of this set of patients with either enzalutamide or abiraterone acetate have shown similar outcomes? We really don’t know." Click on this link to read an article in the New Prostate Cancer Infolink about a recent Phase II trial.
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