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 [...]

More Issues Raised About Cross-Resistance Between Abiraterone and Enzalutamide

Some of my posts over the last week or two have discussed the issue of the development of cross-resistance of two of our newest treatments for advanced prostate cancer.  These drugs are abiraterone (Zytiga) and enzalutamide (Xtandi). Currently, both of them are approved for use after a man has failed chemotherapy with docetaxel. In addition, [...]

Castrate Resistant Prostate Cancer- What To Do Next?

Confusion, confusion and more confusion, that is how I would describe the current decision making process for a man with prostate cancer that has become newly castrate resistant. Just a few years ago the decision tree was clear, castrate resistant, immediately on to chemotherapy with docetaxel. Today, in this treatment space, we have a number [...]

Xtandi Shows Activity in Men with Prostate Cancer Resistant to Chemotherapy and Zytiga

Since its FDA approval in 2011 FDA abiraterone (Zytiga) has supplanted docetaxel (chemotherapy), other than perhaps Provenge, as preferred first-line treatment for metastatic castrate-resistant prostate cancer. August 2012 saw the FDA approval of enzalutamide (Xtandi) for the treatment of castrate-resistant prostate cancer after chemotherapy. Researchers performed a retrospective chart review at a large medical oncology [...]

A Personal Story with A Solution to An Uncommon Side Effect From Xtandi

I was lucky enough to have a consultant here in the UK who was able to get me Enzalutamide (Xyandi) on a compassionate use basis. It worked well for some six months for which I am very thankful but I suffered from an unusual, though listed, side effect. Apart from fatigue, which seems to be [...]

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