Malecare was actively involved, along with its partners, in setting up the early access trial for enzalutamide (Xtandi). The trial was conducted after the final Phase 3 AFFIRM trial that was eventually used to obtain FDA approval had been stopped, but before the FDA and received the final submission of the data. Given the significant [...]
Want your insurance company to pay for next drunk? According to the FDA they in fact might be willing! All kidding aside, the FDA has issued a drug safety communication regarding the risk of intoxication with some of the intravenous generic prostate cancer chemotherapy (docetaxel) formulations containing ethanol. The drugs are marketed as generic docetaxel [...]
The FDA approved Abiraterone acetate (Zytiga) plus prednisone because it demonstrated a survival benefit for men with metastatic castrate resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Given the newness of the approval of Zytiga in this disease stage there is a lack of data on how Zytiga affects the efficacy of enzalutamide (Xtandi) or [...]
Hormone therapy or Primary androgen deprivation therapy (PADT) is the usual first “go to” therapy for men when they are diagnosed with metastatic prostate cancer whether it is a primary diagnosis or the result of a recurrence. The natural progression of the disease is to become unresponsive to the treatment (castrate resistant) leading to a [...]
Xgeva is used in men with advanced and metastatic prostate cancer with bone metastases for the prevention of developing additional skeletal-related events (not to be confused with bone mineral density). In a phase 3 trial, the 147 Study, evaluating denosumab (Xgeva) versus placebo 1,432 men with castrate-resistant prostate cancer demonstrated that Xgeva improved median bone [...]