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"
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"
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"
Reuters and WAll Street Journal report today that Dendreon plans to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon "expects regulators to act on the application by the middle of next year, the company said on Thursday."
To start from an updated report in the Wall Street Journal, which adds this information to Reuters' coverage of Dendreon 's share prices today. The points are excerpted and reordered: ...continue reading "Dendreon to seek Provenge approval in November – Reuters"
“These results confirm the clinical value of Provenge to prolong survival in patients with advanced prostate cancer,” said Dr. Philip Kantoff, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and a principal investigator of the Provenge study, in a statement.
"We've been waiting a long time for a drug that is well tolerated and that gives men with advanced prostate cancer another option," said Christopher Amling, chief of urology at Oregon Health & Science University, Portland, Ore., who wasn't involved with the study. ...continue reading "Reactions to Provenge Data"
– Extended Median Survival by 4.1 Months and Increased 3-Year Survival by 38 Percent Compared to Placebo –
– First Active Cellular Immunotherapy for Cancer to Prolong Survival –
– Company to Host Webcast at 5:30 pm ET –
CHICAGO and SEATTLE, April 28, 2009 - Dendreon Corporation (NASDAQ: DNDN) today announced that its pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of significantly improving overall survival compared to placebo. The data were presented at the American Urological Association (AUA) Annual Meeting.
The intent-to-treat analysis demonstrated that:
* PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months);
* PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%);
* The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by the study's design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775); and
* PROVENGE exhibited a favorable safety profile consistent with prior trials.
...continue reading "Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study"