Provenge Review by FDA

Raise A Voice Continues to be Heard . . . News Update 6/5/07 On June 4, the PCRI’s Jan Manarite led a group of about 60 advocates in a march and rally on Capitol grounds in Washington, DC. In a spirit of unity, Raise A Voice was once again a representation of several organizations, and participants from 10 different states. Dr. Mark Moyad helped to inspire the event, and was the keynote speaker. The rally was followed by a meeting with Dr. Andrew von Eschenbach, Commissioner of the FDA, along with several of his staff members. This June 4 effort gained widespread media attention from television, radio, and print media. For more details

Patient Advocates Rally for Provenge June 4th in Washington News update 5/23/07: Washington DC walk & assembly When: Monday, June 4th Meet either: 9:30 am Union Station (Red Line) in front of fountain (Join the walk to assembly). Or – 10:00 am, Upper Senate Park, adjacent to Russell Senate Office Bldg (Join the assembly). Upper Senate Park is a shaded area with a few park benches. Purpose: To “Raise A Voice” for our unified dissatisfaction with recent FDA Provenge ruling, and gain news coverage as the largest D.C. prostate cancer rally ever held (350 or more). We are raising a voice for prostate cancer once again, and the unmet need for more treatment options for advanced prostate cancer patients. We are building on what we accomplished together at the March 29th FDA Advisory Committee review meeting for Provenge (see below). Reasons for assembly: We ARE newsworthy! (ABC, NBC, CNBC, Seattle Times, and Wall St Journal so far) We ARE a powerful voice and force! We ARE a larger group of voting taxpayers than the government seems to realize. We WANT better communication and representation! How can an organization claim to be objective when they've totally lost sight of the object? We ARE the object. The rally is being organized by Jan Manarite of PCRI, and Raise A Voice. Jan helped to organize and coordinate the success at the March 29th FDA Provenge review meeting. Our plan is to make this another memorable, meaningful event for men with prostate cancer. To join the walk and assembly, or for questions, email Jan at june4th@comcast.net More details: Attire: Blue shirt, any type Blue jeans, jean shorts, or jean skirt (or something comparable). Those who have a military or law enforcement job, wear your uniform if you can. Those in the medical field, wear your uniform if you like. (we will have blue rain ponchos in case of inclement weather for $1 donation) Wear comfortable shoes. Bring water. Signs: Inquire with Jan on content. There are strict regulations for signs, but signmakers are welcome. Again, you must inquire with Jan at (239) 395-0995 or june4th@comcast.net Visual Ideas: Bring men & women in uniform. Bring a friend, family member. We are working on having music. We are working on trucks (semi’s) with blue ribbon, etc. Motorcycles canNOT find a place to park, so not a workable idea. More to come…. Rally location: Upper Senate Park - adjacent to Russell Senate Office bldg North of the Capitol Building on Constitution between Delaware and New Jersey Ave See map: http://dcpages.com/Tourism/Maps/Washington_DC_Map/ Parking – we are told there is no parking for private vehicles near the Rally site More on the Metro: - take the Red line to Union Station Go south on Delaware Ave to Upper Senate Park (0.3 mile walk) - take the Blue/Orange line to Capitol South Station Coming out of Capitol South station, go north on 1st or 2nd St. NE Go west on Constitution Ave, NW to Upper Senate Park (0.7 mile walk) - take the Yellow/Green line to Archieves-Navy Memorial Station Go east on Pennsylvania and Constitution Aves to Upper Senate Park (0.8 mile walk) “Walk the Halls” of Congress on June 5th Provenge Now is a patient advocate initiative created to gain immediate FDA approval for the first-ever Active Cellular Immunotherapy treatment for prostate cancer. Survivors hope to extend their lives with a better quality with this new type of landmark treatment. Provenge is a symbol for a new era in prostate cancer treatment. You can make a difference by: 1. Attending the rally on June 4th to let the public see the faces of prostate cancer 2. Writing your congressman or the FDA Commissioner 3. Signing a petition to the FDA For more information go to www.ProvengeNow.org.

 

FDA Delays Provenge News update 5/8/07: The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA (Biologic License Application). The Company is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA, which the Company believes it can supply to the FDA in a timely manner. See the Dendreon Press Release

 

Raise A Voice Sends Message to FDA News update 5/4/07: Raise A Voice sent the following statement to the FDA with 19 prostate cancer groups signed-on The advocates of "Raise a Voice", a grass roots initiative for advance prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and Gene Therapies Advisory Committee meeting on March 29, 2007. We respect and appreciate the importance and difficulty of the FDA’s current process towards decision on approval of Provenge (sipuleucel-T). Given the following points, we would like to reaffirm our position on the need for more treatments with less side effects for advanced prostate cancer. The very favorable risk-benefit ratio of Provenge.   The survival data discussed at March 29th meeting.   The necessity for more treatments for advanced and hormone refractory prostate cancer based on the current US death rate of approximately 27,000 men a year

 

News update 3/29/07: Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration's (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of PROVENGE (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer. If approved for marketing by the FDA, PROVENGE would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. The FDA will now review the advisory committee's recommendations. The Company anticipates a decision on PROVENGE by May 15, 2007. During a Dendreon conference call after the meeting, Mitchell H. Gold, M.D., president and chief executive officer of Dendreon, was asked “What key elements got this over the goal line?” He mentioned “the work of his team, the survival data and the comments from the patient advocates”. Thanks for all who made presentations, those who attended and those who submitted E-comments to the FDA. See Voice Raised At FDA Hearing See NBC story on Jan Manarite's participation.

(Posted March 16, 2007)

Many of you are familiar with the drug Provenge (sipuleucel-T). This drug has finally been submitted to the FDA for approval to bring to the US market. The day is here.

An FDA committee called the Cell Tissue and Gene Therapy Committee (CTGT) will be reviewing the drug to make a recommendation to the FDA. This committee will recommend that it be approved – or not be approved. It is that simple. FDA is not required to follow their recommendation, but usually does. The FDA will make final ruling some time in May of this year. The indication being filed for is "asymptomatic, metastatic, hormone-refractory" prostate cancer.

Raise A Voice is looking for people who are able to attend the meeting on Thursday, March 29th or to email comments to the committee.

Where: Hilton DC North; 620 Perry Rd; Gaithersburg, MD; 20877; (301) 977-8900.
Web site: Hilton Washington DC North/Gaithersburg Web page

When: Thursday, March 29th; 8:00 am to ? pm. The meeting will at least go through 12:30 pm, when one hour of public comment ends. If you would like to register for public comment, please call Jan Manarite at (239) 395-0995, or (239) 691-3049 cell.

Plan: Raise A Voice would like to help coordinate a visual presence at this meeting. We will be passing out blue lanyards for everyone to wear. This will create something that the committee can easily see, as far as support of the prostate cancer community.

Raise A Voice would like to help prepare people who are interested in giving public comment between 11:30 am & 12:30 pm. Please call Jan Manarite ASAP if you are interested in giving comment. (numbers above)

Raise A Voice would like to have a meeting in the hotel the night before (March 28th). Time and place to be announced.

Raise A Voice will be preparing to interact with committee members during all breaks. We still need someone to volunteer to research the different members of the committee. Please contact Jan Manarite if you can help.

Email Comments
For those who cannot attend the March 29th meeting in Maryland, where Provenge will be reviewed, emailed comments to the FDA are also valuable. Again, Provenge (sipuleucel-T) will be discussed and reviewed by the Cell Tissue and Gene Therapy Committee (CTGT) for recommendation for FDA approval for "asymptomatic, metastatic, hormone-refractory" prostate cancer. You can send an email (or "ecomment") to the FDA by 5:00 pm, EST, March 22nd requesting that Provenge (sipuleucel-T) be approved. Keep in mind that the FDA may get several hundred of these emails, and also keep in mind that these emails will be posted publicly on the FDA Web site later. Therefore, do not include any personal information that you don’t want to be made public.

PLEASE FORWARD this information to anyone else who would also like to send an email in support of having Provenge on the market for men with prostate cancer. This is not an endorsement of any drug company, and not intended to advise anyone about taking or not taking Provenge. We are simply stating that this drug needs to be approved, on the market, and available to men with prostate cancer. Please also remember that in 2005, Xinlay (atrasentan) was denied approval by the FDA for prostate cancer. Combidex (ferumoxtran-10) was also previously denied approval. This is our chance to make sure Provenge doesn’t succumb to the same fate.

Here are some fast facts about Provenge (sipuleucel-T).

• Belongs to a new class of drugs called immunotherapy, designed to train the body’s immune system to fight the cancer itself.
• Works on the protein PAP (prostatic acid phosphatase), which is expressed by over 90% of prostate cancers.
• Is an IV treatment, typically given in three infusions over a one-month period.
• Side effects are substantially less than chemotherapy, and even hormone therapy. Side effects may include low grade fever and transient headache or muscle aches.
• Recently showed improved survival benefit over placebo in men with advanced prostate cancer. This trial was led by Dr Eric Small from UCSF.

Reference - Cancerfacts.com article

Here are some facts about advanced prostate cancer:

For early stage prostate cancer there are approved treatments that provide effective control for many. We encourage these men to utilize available treatments or to seek out clinical trials.

Many people believe that few men die of prostate cancer but about 30,000 do and 48,000 more are dealing with hormone refractory disease. “We are over-treating [early] prostate cancer, period. The Government knows that. The insurance companies know that. The media knows that. We are vastly under-treating advanced prostate cancer.” (Dr. Donald Coffey at the Advanced Prostate Cancer Advocacy meeting, 2/23/06).

There has been a substantial decline in the death rate for all prostate cancer due to earlier diagnosis and treatment (ACS, Cancer Facts and Figures 2005, p2). However, the death rate for advanced disease and the number of men with advanced disease remain critical concerns.

Men diagnosed with prostate cancer that is not confined to the prostate or who have recurrence following local therapy have advanced prostate cancer. Advanced Prostate Cancer progresses to to Androgen Independent (AIPC), also known as Hormone Refractory (HRPC), disease for which there is only one FDA approved treatment.

Areas of Concern
There are not enough effective therapies for metastatic androgen independent prostate cancer

There are no FDA approved adjuvant therapies to halt progression for prostate cancer patients who are failing androgen deprivation before evidence of metastases.

More information on Raise A Voice

Prostate Cancer Research Institute (PCRI)
 

Material provided by PCRI is intended for educational purposes for discussion with your physician and should not be considered as medical advice. Information and opinions expressed on this website are not an endorsement by PCRI for any treatment, product or service.