step therapy

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  NICE has issued a final draft guidance recommending that men with hormone-relapsed prostate cancer (castrate resistant) that has metastasized and has been treated with docetaxel (chemotherapy)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 given access to Xtandi (enzalutamide), even if they had prior exposure to Zytiga (abiraterone).  The prior recommendation did not permit men with prior Zytiga exposure to receive Xtandi. NICE changed their original guidance, men who had prior Zytiga exposure would not benefit from Xtandi after [...]

NICE Changes Its Mind & Reverses Its Prior Decision on the Use of Xtandi in the UK!

Live in the UK and have advanced prostate cancer? If you do then be prepared to have economics over-ride your legitimate health concerns. The U.K.'s National Institute for Health and Care Excellence (NICE) makes no bones about what is more important, money or men’s health. NICE initially did not approve Zytiga, however when Johnson & Johnson offered to sell it at an additional discount they changed their tune and agreed that it was a good treatment for men who had castrate resistant prostate cancer. Now, Zytiga’s rival, a much more costly drug, Xtandi has been the subject of a NICE [...]

PLATO – A New Phase 4 Clinical Trial Extending the Use of Xtandi & Combining It with Zytiga

The makers of Enzalutamide (Xtandi), Astellas Pharma US, Inc and Medivation, Inc have begun a Phase 4 clinical trial known as PLATO. The study is designed to evaluate the efficacy and safety of continued treatment with enzalutamide (Xtandi) plus abiraterone acetate (Zytiga) and prednisone as compared to treatment with Zytiga and prednisone alone in men who have not yet had chemotherapy treatment for advanced prostate cancer that has advanced following failed therapy with Xtandi. This trial will be global; randomized; double blind; placebo-controlled and scheduled to enroll approximately 500 chemotherapy-naive men. All subjects will initially receive treatment with Xtandi. Those [...]

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 treated with placebo be offered enzalutamide." Enzalutamide (Xtanndi) reduced the risk of death by 30% (Hazard Ratio .70), and patients saw an 81% reduction in risk of radiographic progression or death (Hazard Ratio 0.19), Dr. Tomasz Beer, professor of medicine and deputy director of the [...]