Slide 1

PROSTATE
CANCER
&
PROVENGE

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Slide 2

BACKGROUND
INTRODUCTION
• According to the 2003 CDC data, 30,000 men/year
(82 men/day!) will die from prostate cancer.

The average life expectancy for a terminal

prostate cancer victim is about 19 months. The
only FDA approved treatment for these patients is
a chemotherapeutic drug with severe side effects,
which only extends life expectancy some 10
weeks. The present chemotherapy for these
patients is so toxic and marginally effective, most
terminal prostate cancer patients choose not to
take any chemotherapy at all.

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Slide 3

BACKGROUND
INTRODUCTION
 In the early stages, PC often does not cause
symptoms
 By the time symptoms occur, the disease
may have spread beyond the prostate
 The symptoms that may be present are
frequent urination, especially at night, inability
to urinate, trouble starting or holding back
urination, a weak or interrupted flow of urine,
painful or burning urination, blood in the urine
or semen, painful ejaculation, frequent pain in
the lower back, hips, or upper thighs

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Slide 4

BACKGROUND
INTRODUCTION
 EARLY DETECTION IS THE BEST
PROTECTION

 BE SURE TO SEE YOUR DOCTOR

REGULARLY FOR SCREENING AND
YEARLY CHECK-UP

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Slide 5

ABOUT
PROVENGE
 Active Immunotherapy (trains the patients
own body to fight the cancer cells) Drug
For Androgen Independent Prostate
Cancer

 Mild side effects similar to a flu shot

 34% of treated patients alive at 3 years

versus 11% in control group

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Slide 6

ABOUT PROVENGE
(Cont)
 75% of control group patients crossed
over to Provenge on progression

 Provenge group lived an average of 4.5

months longer than control group

 For PC specific survival the Provenge

group lived an average of 11.7 months
longer

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Slide 7

THE PROVENGE STORY

BEGINS….
 On March 29th, the FDA Advisory Panel
voted 17-0 that Provenge is safe

 They then voted 13-4 that Provenge is

effective

 On May 9th the FDA issued a Complete

Response letter delaying Provenge for up
to four years

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Slide 8

THE PROVENGE STORY

BEGINS….
 Provengenow.org was set up to support
Provenge and expedite approval

 Prostate Cancer Survivors and Advocacy

Groups rallied in D.C. on J une 4, 2007 and
Chicago on J une 2, 2007 to express their
dissatisfaction with the FDA’s decision to
delay Provenge

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Slide 9

WHAT WENT
WRONG?
 Three of the panel members voting
against Provenge had Conflict of Interest
Waivers

 Two physicians on the panel had major

COI’s that they did not reveal

 Provenge versus Chemotherapy – You

Decide

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Slide 10

A CALL TO ACTION!!
THINGS YOU CAN DO…
 Contact your senators and representatives to
demand a congressional investigation of the
FDA

 Voice your opinion by calling and writing your

local media outlets, family members, friends,
neighbors and anyone who will listen

 Support your local advocacy groups

 Support and/or attend future rallies

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Slide 11

FOR MORE DETAILED

INFORMATION
GO TO…
 www.provengenow.org

 www.caretolive.com

 www.provenge.blogspot.com

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Slide 12

REFERENCES
 http://www.cancer.gov/cancertopics/factsheet/Detection/early-
prostate

 http://www.cdc.gov/cancer/prostate/basic_info/

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