It comes without any great surprise, but earlier in the month the FDA announced they were giving the application from Astellas and Medivation for a priority review to extend the indication (FDA approved use) for Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. The [...]
The good news is that finally Astellas and Medivation have submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. As of today XTANDI is currently only approved for [...]
It was announced today that after observing significant benefits in overall survival (OS) and radiographic progression free survival (PFS) ,the two co-primary endpoints of the the Xtandi pre-chemotherapy trial, the Independent Data Monitoring Committee (IDMC) for The Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends that "the study be stopped and patients [...]
Recently, the U.S. Food and Drug Administration (FDA), has begun to support the reporting and use of patient-reported outcome measures (PROMs) of symptoms as secondary end points in clinical trials for oncology treatment. These outcomes measures are likely to become increasingly important for oncology patients as they will hopefully become part of the drug label. [...]
The first line of treatment for advanced prostate cancer is Androgen (male hormone) Deprivation Therapy or ADT. Once the PSA progresses (climbs) while still on ADT and with testosterone levels