What will happen when enzalutamide (Xtandi) is approved for use in advanced prostate cancer in the disease stage prior to chemotherapy (that is if it is approved)? Already occupying this space and already approved by the FDA is both Provenge and abiraterone (Zytiga). Where will Xtandi fit in? Until we have a lot more data, [...]
Prostate cancer is commonly associated with lower urinary tract symptoms (LUTS). The use of GnRH agonists or antagonists (first line ADT) is widely used as the primary treatment for advanced prostate cancer (pc) and/or to reduce prostate volume (TPV). It is thought that the ADT contributes to the development of LUTS. Researchers pooled multiple other [...]
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 [...]