ASCO 2014: Combining Advanced Hormone Therapies (Zytiga & Xtandi) Shows Promise for Men with Advanced Prostate Cancer

In my continuing reports about interesting and pertinent information released at the ASCO 2014 meeting one abstract described a phase 2 trial combining an attack on androgens in metastatic prostate cancer resistant to initial hormone therapy.  This proof of concept study showed that combining Enzalutamide (Xtandi) plus abiraterone (Zytiga)  drove down testosterone levels and appeared [...]

Preliminary Data Released for A Phase II Trial of Sipuleucel-T (Provenge) with Concurrent or Sequential Enzalutamide (Xtandi) in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

There will be an abstract presented at the Upcoming (May 31- June 3) American Society of Clinical Oncologist Annual Meeting (ASCO) providing very preliminary data on a clinical trial combing Sipuleucel-T (Provenge) and enzalutamide (Xtandi) in men with metastatic castrate resistant prostate cancer (mCRPC).  This rational for conducting this trial is the lack of cross [...]

NICE Recommends Xtandi for Men with Prior Zytiga Exposure – Good News for our Brothers and Ammunition to Appeal Step Therapy

There is some really good news for those of us who live in areas where The National Institute for Health and Care Excellence (NICE) recommends drug approvals.  NICE has issued a final draft guidance recommending that men with hormone-relapsed prostate cancer (castrate resistant) that has metastasized and has been treated with docetaxel (chemotherapy) should be [...]

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 [...]

Sorting Out Prostate Cancers that Are Resistant to Enzalutamide (Xtandi)

Over the last several years’ prostate cancer treatment options for men with advanced prostate cancer has gone from rags to riches.  We now have multiple options for treatment and there is every indication that the number of options will continue to grow. However, we do see that not all men will respond to all treatments.  [...]

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, [...]

There is Some Cross Resistance Developed Between Both the First Use of Zytiga and the First Use of Xtandi

On March 4, 2014 I wrote a post “Castrate Resistant Prostate Cancer- What to Do Next” ( The basic theme of the post was about how difficult it is to know how to sequence the new drugs we have to treat advanced prostate cancer (metastatic castrate resistant prostate cancer aka mCRPC). In the post I [...]

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 [...]