FULL PRESCRIBING INFORMATION

THE SCIENCE BEHIND PROVENGE: POWERFULLY PERSONAL

As an immunoevasive disease, prostate cancer can evade or inhibit the body's natural immune process, allowing cancer cells to grow and spread, virtually unchecked.

PROVENGE immunotherapy works differently from other advanced prostate cancer treatment options. With PROVENGE, a patient's own immune cells are collected during leukapheresis.

These autologous cells are sent to a state-of-the-art manufacturing facility where, during a rigorously controlled process, the cells are cultured with PAP-GM-CSF, a proprietary recombinant protein consisting of

— 
prostatic acid phosphatase (PAP), an antigen expressed on more than 95% of prostate cancer cells
— 
granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that actives the immune system

This antigen complex activates the patient's antigen-presenting cells (APCs). Once each dose of PROVENGE is completed, it is transported back to the patient for infusion. Upon infusion, PROVENGE activates the patient's own APCs, which proliferate. These activated APCs help the immune system target and attack PAP antigen–expressing prostate cancer cells, resulting in a specific and lasting immune response.

PROVENGE is not intended to lower prostate-specific antigen (PSA) level, however data suggest that men who start PROVENGE when their PSA level is lower live longer.1,2

IDENTIFYING PATIENTS WHO ARE READY FOR PROVENGE

Indicators that men with prostate cancer may be ready to start PROVENGE3

Confirmed metastatic disease: Diagnosed metastatic disease, generally confirmed via imaging

Progression on ADTa: As an immunoevasive disease, prostate cancer can progress despite the use of hormone therapy such as androgen deprivation therapy (ADT)

Testosterone <50 ng/dL: Men are at castrate levels when their testosterone drops below 50 ng/dL; this result can be achieved biochemically or surgically

Does not take narcotics for cancer pain: Men with severe bone pain related to metastatic disease were not eligible for inclusion in IMPACT

aRadiographic evidence of disease progression or rising PSA level.

POTENTIAL CANDIDATES FOR PROVENGE

PROVENGE is indicated for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).3

PROVENGE may be appropriate for many types of patients. Consider:

Men with newly diagnosed mCRPC

Studies suggest that men who receive PROVENGE when their PSA level is lower live longer.1,2

Sipuleucel-T Immunotherapy patient

Men with disease progression directly from metastatic hormone-sensitive prostate cancer (mHSPC) to mCRPC

Disease progression from mHSPC to mCRPC can occur radiographically or biochemically: mHSPC + progression = mCRPC.

Once diagnosed metastatic, always metastatic

When a man is diagnosed with metastasis, he remains metastatic, regardless of how his disease progresses.

Men without a rising PSA

Men with nonmetastatic CRPC may develop metastasis while their PSA level remains stable or even declines.

Men who are no longer symptomatic

Men whose symptoms have improved due to other interventions and no longer require narcotics for cancer-related pain.

Men with mCRPC who are being treated with other therapies

PROVENGE does not have any contraindications.

PROVENGE IMMUNOTHERAPY WORKS DIFFERENTLY

TARGETED MECHANISM OF ACTION3

See how PROVENGE transforms resting antigen-presenting cells (APCs) into active APCs.

Beginning with leukapheresis, the patient’s own immune cells, along with some platelets and red blood cells, are collected.

These autologous cells, including APCs are then delivered to a state-of-the-art manufacturing facility where, during a timely and rigorously controlled process, the cells are cultured with a recombinant antigen, PAP-GM-CSF.

PAP is an antigen expressed on more than 95% of prostate cancer cells.

GM-CSF is a cytokine that activates the immune system. Together, these fused proteins specifically train and activate the collected APCs.

In vitro, as the patient's APCs process PAP-GM-CSF, they begin to present pieces of the antigen on their surface.

Once each dose of PROVENGE is completed, it is transported back to the patient for infusion.

Upon infusion, PROVENGE activates the patient's own resting T cells, which proliferate.

Activated T cells help the immune system target and attack PAP antigen-expressing prostate cancer cells, resulting in a specific and lasting immune response.

This autologous treatment cycle using the antigen PAP-GM-CSF occurs 2 additional times over the course of about a month, empowering the patient’s immune system to effectively fight advanced prostate cancer.

THE VALUE OF PERSONALIZED THERAPY WITH PROVENGE

As the first FDA-approved, personalized immunotherapy for prostate cancer, PROVENGE works differently from treatments such as hormone therapy or chemotherapy by generating a robust, personalized immune repsonse.3

PROVENGE is made by culturing a patient’s own immune cells with a recombinant protein that is prostate specific. When infused into your patient, PROVENGE activates resting APCs to target and attack his prostate cancer.3

With a unique mechanism of action that leverages the immunological memory inherent in the immune system, PROVENGE provides a lasting immunological advantage for your patient with advanced prostate cancer. Data suggest that men who start PROVENGE with a lower PSA level live longer. 1,2,a

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

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.
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
3.
PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
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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