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"
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"
In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.
...continue reading "Provenge and Meta-Analysis — Compare Avandia"
A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.
A full written transcript in .pdf including the voting is online at FDA, click here.
A crowd of about 70 people led by prostate cancer advocates marched and rallied in Washington, D.C. on June 4 to call on the FDA to Approve Provenge Now.
Thomas Farrington of Prostate Health Education Network addressed the group.
Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.
The petition campaign was organized by malecare.com.
Organizer Jan Manarite receives a hug
from her son, who carried the message
"Help My Dad Live"
On June 5, campaigners met with FDA director Andrew von Eschenbach.
Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon's Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.
...continue reading "Prostate Cancer Doctor Receives Death Threat Over Provenge"