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
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
Jan Manarite of Raise a Voice Campaign writes:
Prostate cancer patients have been watching for the prostate cancer/Provenge story on ABC World News with Charles Gibson. I just got a call from Dr Moyad that ABC called the prostate cancer patient who was interviewed for that story, and informed him that it would air Monday night, June 4th. This appears to be a commitment. Did ABC wait for our June 4th DC rally?
Continue reading ABC-TV Provenge Story Expected to Air Monday June 4
Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.
In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”
Continue reading Dendreon Says FDA Will Accept Either Interim or Final Analysis