Early/Expanded Access Programs

///Early/Expanded Access Programs

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and my own caretaker, Wendy Lebowitz. Anyone reading the first edition will be surprised when you see how many changes and updates this edition has included. It now has a very extensive conversation about living in the world as a cancer survivor as well as more [...]

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 positive results of the trial we felt that the drug needed to become available to those in need even though the FDA had not yet approved the treatment. We accomplished this task by creating an Open-Label Single-Arm study to designed to monitor the drug’s safety [...]

Zytiga in Québec, Radium-223 in England & Lets Change Our Antiquated Approval Nonsense

Men with metastatic castration-resistant prostate cancer (mCRPC) in Québec, Canada now have access to Zytiga (abiraterone acetate) prior to having chemotherapy. Effective February 3, 2014, the province has added ZYTIGA to the public drug formulary for the treatment of mCRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT). In July 2011, ZYTIGA was approved by Health Canada for the treatment of men with mCRPC who had received prior chemotherapy containing docetaxel after failure of ADT. Health Canada approved a second indication for ZYTIGA in May 2013 for the treatment of men with mCRPC [...]

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 [...]

スーパーコピーブランド ロレックススーパーコピー オメガスーパーコピー ブルガリスーパーコピー ブライトリングスーパーコピー カルティエスーパーコピー シャネル時計コピー IWCスーパーコピー フランクミュラースーパーコピー パネライスーパーコピー タグホイヤースーパーコピー ウブロスーパーコピー ガガミラノスーパーコピー ルイヴィトンスーパーコピー シャネルスーパーコピー エルメススーパーコピー グッチスーパーコピー ボッテガヴェネタスーパーコピー プラダスーパーコピー セリーヌスーパーコピー ロレックススーパーコピー ウブロスーパーコピー