FULL PRESCRIBING INFORMATION

WHY PROVENGE?

PROVENGE is the first personalized, FDA-approved, immunotherapy that is clinically proven to extend life for certain men with metastatic castration-resistant prostate cancer (mCRPC).

why PROVENGE

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

PROVENGE works differently from other advanced prostate cancer treatment options by using the patient's own immune cells, cultured with a recombinant protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-cell activator. With a unique mechanism of action, PROVENGE provides a robust immune response with a manageable safety profile.

In a post hoc analysis of the PROCEED Registry,

men with mCRPC with a baseline prostate-specific antigen (PSA) level ≤5.27 ng/mL who received PROVENGE had a median overall survival of nearly 4 years.1

aPROCEED was a registry without a control group where all patients received PROVENGE. Patients may have received subsequent anti-cancer interventions per the local investigator's standard of care.

Some patients have experienced serious adverse events while taking PROVENGE. See Important Safety Information for more details.

LEARN MORE ABOUT THE PROCEED REGISTRY >>

IN IMPACT, PROVENGE SIGNIFICANTLY EXTENDED OVERALL SURVIVAL IN PATIENTS WITH mCRPC2

IMPACT, the pivotal clinical trial, showed that men who received PROVENGE lived 4.1 months longer than men in the control group. However, a post hoc analysis showed that men who started PROVENGE with lower PSA levels lived even longer.3,b

bThis post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.

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MANAGEABLE SAFETY PROFILE

The most common side effects of PROVENGE are generally mild to moderate and well tolerated.

Some patients have experienced serious adverse events while taking PROVENGE. See Important Safety Information for more details.

LEARN MORE ABOUT THE SAFETY PROFILE >>

A PROLONGED EFFECT

A sustained immune response of up to 26 weeks (the last time point measured) was observed in men who received PROVENGE in IMPACT.c

cNo conclusions could be made regarding the clinical significance of the observed immune response.4

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THE IMPORTANCE OF PATIENT IDENTIFICATION

Early identification of men with mCRPC who are indicated for PROVENGE is key to achieving optimal clinical benefit. Almost 25% of men assumed to have nonmetastatic CRPC were found to have metastatic disease when screened via imaging.5

According to the National Comprehensive Network® (NCCN®), sipuleucel-T (PROVENGE) may be considered for men with mCRPC if they didn't receive it as initial therapy.6

HELPING PATIENTS NAVIGATE THEIR TREATMENT OPTIONS

For men with prostate cancer, understanding the available treatment options can be challenging.

For example, in IMPACT, PROVENGE was shown to provide a survival advantage in men regardless of their baseline PSA level. However, post hoc analyses reveal that there's more to the story. In fact, data suggest that men who start PROVENGE when their PSA level is lower live longer.3 This substantiates the importance of regular imaging to diagnose metastatic progession as early as possible.

Your patient may find it helpful to hear from others who have been in his shoes and have chosen PROVENGE to improve their chances of living longer.

PROVENGE patient and doctor

FAQ ABOUT PROVENGE

As the first personalized immunotherapy for prostate cancer, PROVENGE is unlike other treatments such as hormone therapy, chemotherapy, or surgery. Find answers to frequently asked questions about PROVENGE.

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References:
1.
Higano CS, Armstrong AJ, Sartor AO, et al. Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer. Cancer. 2019;125(23):4172-4180. doi:10.1002/cncr.32445
2.
Kantoff PW, Higano CS, Shore ND, et al; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5):411-422. doi:10.1056/NEJMoa1001294
3.
Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013; 81(6):1297-1302.doi:10.1016/j.urology.2013.01.061
4.
PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
5.
Smith MR, Saad F, Chowdhury S, et al; SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl Med. 2018;378(15):1408-1418. doi:10.1056/NEJMoa1715546
6.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Guideline Name V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed May 21, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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