Tag Archive > Provenge

Provenge available for men with advanced prostate cancer at Roswell Park

» 15 February 2011 » In Hormone refractory, Immunotherapy, Metastatic, PCa Treatments, Prostate Cancer, Provenge, Vaccines » Comments Off

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.

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Provenge Trial Ongoing & Recruiting At Eight US Centers

» 25 November 2009 » In Clinical trials, Dendreon, Prostate Cancer, Provenge, Vaccines » Comments Off

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.

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Dendreon to seek Provenge approval in November – Reuters

» 24 September 2009 » In Prostate Cancer, Provenge, Vaccines » Comments Off

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:

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Provenge and Meta-Analysis — Compare Avandia

» 07 July 2007 » In Chemotherapy, Clinical trials, FDA, Prostate Cancer, Provenge » Comments Off

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.

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Video of FDA hearing on Provenge March 29th

» 07 June 2007 » In Clinical trials, Provenge, Vaccines » Comments Off

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.

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Prostate cancer patients, families, rally in Washington D.C.

» 05 June 2007 » In Prostate Cancer, Provenge » Comments Off

Prosstate cancer patients, families and advocates rally in Washington DC June 4th to demand Approve Provenge Now

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

Thomas Farrington of Prostate Health Education Network addressed the group.

Jan Manarite of Raise a Voice

Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.

Podium with Jan, Thomas Farrington, malecare petition poster

The petition campaign was organized by malecare.com.

Visit Joel Nowak’s advancedprostatecancer.net blog,
Provenge Advocacy Hits the News

Help My Dad Live! sign carried at Prostate Cancer rally

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.

View ABC-TV video here. See photos of the rally (by brad.wick) and video of Mark Moyad’s speech.

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Prostate Cancer Doctor Receives Death Threat Over Provenge

» 03 June 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » 4 Comments

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.

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ABC-TV Provenge Story Expected to Air Monday June 4

» 02 June 2007 » In Prostate Cancer, Provenge, Vaccines » Comments Off

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?

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Provenge Now Campaign Reaches AUA and Heads to Washington

» 22 May 2007 » In Clinical trials, Prostate Cancer, Provenge, Vaccines » Comments Off

Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.

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