Enzalutamide (Xtandi) has a new, expanded FDA label. The new label conforms with the clinical trial (TERRAIN) results that Xtandi is a superior drug to Casodex (bicalutamide) for men with metastatic castration-resistant prostate cancer (CRPC). The updated product label shows enzalutamide reduces the risk of radiographic progression or death by 40% vs. bicalutamide. Median radiographic [...]
Nizoral (ketoconazole, keto) is an older drug that has been used as a part of hormone therapy (ADT) for many years. Keto, which is an inexpensive anti-fungal drug had been used for many years as an inhibitor of adrenal androgen synthesis as is abiriterone (Zytiga). Ztiga has been shown to be more effective, however, it [...]
Yes, it is true, many clinical trial results are not published, especially negative results. This is even true for FDA approved drugs and treatments! Failing to publish, or actually hiding negative results and harmful side effects that occur in clinical trials is too common and jeopardizes each and everyone of us, including survivors of advanced [...]
The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don't work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these [...]
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 [...]