Since it FDA approval in 2004, docetaxel (a taxane based chemotherapy) has been the standard first-line chemotherapy for men with metastatic prostate cancer (mCRPC). Other than the trial of Provenge all the successful phase III trials conducted in mCRPC focused on men experiencing cancer progression after first-line docetaxel chemotherapy. The implication is that improving the [...]
Some good news for men who are living in Japan and dealing with advanced prostate cancer. It was announced that Astellas and Medivation have submitted an application for marketing approval of Enzalutamide (Xtandi) in Japan. Their application is based on results obtained from the global Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 [...]
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted approval of Xtandi in the treatment of men with castrate resistant prostate cancer that has progressed after the use of chemotherapy. It has already been approved for use in the United States. Xtandi (aka Enzalutamide and MDV3100) is a strong androgen [...]
I don’t understand why if I have hormone resistant advanced prostate cancer why the new drugs, Zytiga and Xtandi work. These drugs are still hormone therapies, is my prostate cancer hormone resistant? I recently received an email asking me this question and I thought it might be a question many people have, so I am [...]
There was a recent interview in the Pharma Strategy Blog with Dr. Bertrand Tombal , an academic urologist in Belgium. Dr. Tomal discussed several of the new advances in the treatment od advanced prostate cancer with an emphasis on the potential future of Enzalutamide (Xtandi). Like bicalutamide (Casodex), Xtandi works by blocking (inhibiting) testosterone from [...]
Medivation, the pharmaceutical company that owns Xtandi (formerly known as MDV-3100), the new androgen receptor antagonist to treat castrate resistant advanced prostate cancer has a number of active clinical trials, despite the fact that it has already been approved for use. The current FDA approval is specific; it has been approved for men who are [...]
The summer is coming to a close and I am back, ready to again take on the world. I had the fantastic opportunity of spending almost two weeks in Alaska, a land that is so different from the lower 48. I have to say that I have a new found respect for those individuals who [...]
The U.S. Food and Drug Administration today, August 31, 2012 approved Xtandi® (MDV3100) (enzalutamide) capsules to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with chemotherapy, Xtandi was reviewed under the FDA’s priority review [...]
