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.
Category > PCa Treatments
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.
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.
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.
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.
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.
BY DOUGLAS SCHERR M.D.
Obesity is becoming an increasing concern with regard to prostate cancer treatment decisions as the number of patients with a Body Mass Index (BMI) of greater than 30 grows. While there hasn’t been conclusive study into the area, it has been generally found that obesity is a negative risk factor for prostate cancer.
The American Society for Radiation Oncology (ASTRO) will host news briefings with accompanying live webcasts on the top cancer research papers from its 51st Annual Meeting to be held this coming week in Chicago. Prostate cancer features in three of briefings. Here are the headlines:
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:
Rick Ward, of Deer Lodge, Montana and San Antonio,Texas, a pioneering prostate cancer awareness advocate and activist, died recently of chronic obstructive pulmonary disease (COPD).
Rick, an Air Force veteran aged 71, will be remembered for his tremendous contribution to Seedpods brachytherapy mailing list, for his dedication to helping Veterans faced with cancer and other health problems, for popularizing the sky blue ribbon as an emblem of prostate cancer awareness, and for advocating for equitable funding for prostate cancer research.
Rick discovered he had prostate cancer at age 56 in September 1994 in Deer Lodge, Montana when a PSA test at a free screening clinic during Prostate Cancer Awareness Week came back at a high 14 ng/mL. He called the National Cancer Institute at 1-800-4CANCER; and as an early internet user, he joined one of the start-up online mailing lists.