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Enzalutamide Prescribing Info Includes New Information

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 [...]

Caution – The FDA Has Limited The Usage of Nizoral (ketoconazole)

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 [...]

US Government Begins to Crack Down on Clinical Trials Reporting

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 [...]

We Need to Report Serious Adverse Events or Serious Drug Side Effects to the FDA – How You Can Make a Report

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 [...]

Results of the Earl Access Trial of Enzalutamide Leading to the FDA Approval

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 [...]

Xtandi Receives an FDA Review Date for Pre-Chemotherapy Use

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 [...]

Application for the FDA Approval of Xtandi in the Pre-Chemo State Has Finally been Submitted

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 [...]

Positive Results for Xtandi in the Pre-Chemotherapy Space

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 [...]

Changes in Clinical Trials – The Addition of Patient Reported Outcomes

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. [...]

Commonly Used FDA Approved Treatments for Metastatic Castrate Resistant Prostate Cancer (mCRPC)

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

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