Sunday, December 23, 2012

ADVANCES IN PROSTATE CANCER
In advanced prostate cancer
TREAT FIRST LINE WITH PROVENGE TO
EXTEND SURVIVAL
Prescribing Information
PROVENGE extends median survival beyond 2 years in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer

PROVENGE reduced the risk of death by 22.5% vs the control group (P=0.032)¹
Overall Survival Benefits of PROVENGE1,2
Data originally published in The New England Journal of Medicine: Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

Average time to subsequent therapy with docetaxel in the IMPACT trial was approximately 1 year.¹
PROVENGE provides a sustained survival benefit and a durable immune response

PROVENGE provided a survival benefit every year studied³
Overall Survival Benefit for PROVENGE3
*(Percent PROVENGE-percent control)/percent control.
Percentage of Patients Alive: ITT Population (95% CI)3
1 year 2 years 3 years 4 years
PROVENGE 81.1%
(76.9, 85.3)
n=274
52.1%
(46.4, 57.7)
n=129
31.7%
(25.7, 37.8)
n=49
20.5%
(14.0, 26.9)
n=14
Control 72.4%
(65.6, 79.1)
n=123
41.2%
(33.5, 49.9)
n=55
23.0%
(15.5, 30.5)
n=19
16.0%
(8.5, 23.4)
n=4
ITT=intent-to-treat.
PROVENGE provided a durable immune response²
•  A sustained immune response to PROVENGE was seen out to 26 weeks in the pivotal study (the last time point measured)
PROVENGE provides a safety profile you and your patients can manage
Only 1.5% of patients treated with PROVENGE in the pivotal trial discontinued treatment due to adverse events²
The most common adverse events reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache²
INDICATION
PROVENGE® (sipuleucel-T) is approved by the FDA as an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
IMPORTANT SAFETY INFORMATION

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Please see the Full Prescribing Information.
Visit www.PROVENGE.com to learn more about
treating advanced prostate cancer
REFERENCES
1. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
2. PROVENGE [package insert]. Dendreon Corporation; June 2011.
3. Data on file. Dendreon Corporation.
©2012 Dendreon Corporation. All rights reserved.
P-A-10.12-281.00
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