Prostate cancer survivors during the era 2005-2013, as you'll see from our tag cloud (sidebar), were bombarded by Dendreon's controversial campaign to speed FDA approval of its immunotherapy vaccine Provenge. Since then, Provenge hype has calmed down, while the push for Abiraterone acetate (Zytiga) has heated up.
Abiraterone (generic name) aka Zytiga (brand name) is a high-powered castration drug FDA approved for use with 10-mg prednisone as a treatment for men with metastatic CRPC. Compared to Provenge, which costs around $90,000 for a course of treatment, Zyiga costs about $5,000 a month with expected follow-up doses for around eight months.
Janssen, Zytiga's manufacturer, is pushing to extend the drug for men with high-risk nonmetastatic (M0) castration-resistant prostate cancer (CRPC). According to a study by Dr. David Crawford and colleagues,, abiraterone (Xytiga) "significantly lowered PSA levels with a consistent toxicity profile in men with high-risk nonmetastatic (M0) castration-resistant prostate cancer (CRPC)."
...continue reading "Zytiga Lowers PSA in men with high-risk prostate cancer, at a cost in side-effects"
February 7 2011, BUFFALO, NY — The nation’s first FDA-approved cancer treatment vaccine, Provenge (sipuleucel-T), is being offered for the first time in Western New York at Roswell Park Cancer Institute (RPCI). The vaccine is designed for men with advanced prostate cancer who have limited treatment options and who meet eligibility requirements. ...continue reading "Provenge available for men with advanced prostate cancer at Roswell Park"
Robot assisted prostate surgery, known medically as the da Vinci prostatectomy, has had a profound influence over treatment during the past decade. Robotic surgical technology was first developed by the military for use in the battlefield. However during the past decade, this technology has been rapidly applied to the general medical setting, notably in the field of prostate cancer. ...continue reading "How does a robotic prostatectomy work?"
Dendreon is pricing Provenge high and for the first year its availability will be low, according to a report today in Xconomy, a Seattle business website. Provenge, the first immunotherapy to win FDA approval for treatment of men with prostate cancer, will cost $93,000 per patient. Only 2,000 patients will be treated with Provenge in the first year.
...continue reading "Dendreon Sets Provenge Price at $93,000 – Only 2,000 Patients Will Get it in First Year"
SEATTLE, April 29, 2010 --Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) has approved PROVENGE(®) (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Provenge is designed to induce an immune response against Prostatic Acid Phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.
...continue reading "FDA Approves PROVENGE ® for the Treatment of Men with Advanced Prostate Cancer"
In light of favorable results from the Phase 1-2 trial of MDV 3100 for advanced prostate cancer, a Phase 3 trial is enrolling at sites in the US, Canada, South America, UK, Europe, Australia, and South Africa. Results from the earlier trial are published online by the UK medical journal The Lancet. ...continue reading "Phase 3 Trial Underway for MDV 3100 for Advanced Prostate Cancer"
An open-label study of Sipuleucel-T (Provenge) is ongoing at 8 centers across the USA. This is a Phase 2 Study enrolling men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
The aim of this study is to measure the immune responses to treatment with sipuleucel-T (Provenge). All participants will receive the drug. ...continue reading "Provenge Trial Ongoing & Recruiting At Eight US Centers"