PROVENGE: IMMUNOTHERAPY IN A MONTH¹

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). It is the first FDA-approved immunotherapy for prostate cancer.

PROVENGE is made by culturing a patient's own immune cells with a recombinant antigen^a that is prostate specific. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer cells.

^aThe recombinant antigen used to make PROVENGE is called PAP-GM-CSF. It consists of prostatic acid phosphatase (PAP), an antigen expressed in more than 95% of prostate cancers, and granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator.

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

PROVENGE is manufactured by Dendreon Pharmaceuticals, LLC, headquartered in Seal Beach, California. Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of treatments that harness the power of the immune system to extend life. Dendreon’s flagship product, PROVENGE^® (sipuleucel-T), was the first FDA-approved immunotherapy to be made from a patient’s own immune cells. Nearly 40,000 men with advanced prostate cancer have been prescribed PROVENGE in the United States since 2010. For more information, please visit www.dendreon.com.

Immunotherapy is a treatment that empowers the immune system to identify and fight foreign substances such as cancer and other diseases. PROVENGE is a personalized immunotherapy for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROVENGE is made by culturing a patient’s own immune cells with a recombinant protein that is prostate specific. When infused into the patient, PROVENGE activates resting T cells to target and attack prostate cancer.

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

On this website, you can find information about PROVENGE survival data, mechanism of action, and safety profile.

A PROVENGE treatment brochure and video were created for men who are considering treatment with PROVENGE. Your patients may find it helpful to review the brochure with you or a member of your staff. You may also direct your patients to the PROVENGE website for patients.

DOWNLOAD THE PROVENGE TREATMENT GUIDE : IN ENGLISH >> IN SPANISH >>

PROVENGE may help extend life for certain men with mCRPC. Men who receive PROVENGE when their prostate-specific antigen (PSA) level is lower may live longer.

In a post hoc analysis of the PROCEED Registry, men who started PROVENGE when their PSA was ≤5.27 ng/mL experienced^1,a

A post hoc analysis of the pivotal Phase 3 IMPACT trial suggests that men who received PROVENGE when their PSA level was lower experienced

Median survival was 13 months longer for men with a low baseline PSA^d level treated with PROVENGE compared with men who did not receive PROVENGE.

^cThis 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.

^dMedian overall survival improvement was found in all quartiles of the post hoc analysis (PSA ≤22.1 ng/mL, 13.0 months; PSA >22.1-50.1 ng/mL: 7.1 months, PSA >50.1-134.1 ng/mL, 5.4 months; PSA >134.1 ng/mL: 2.8 months). Individual results may vary.

SEE MORE DATA FROM THE IMPACT TRIAL AND POST HOC ANALYSIS OF IMPACT >>

The most common side effects of PROVENGE are generally mild to moderate and well tolerated. In IMPACT, the pivotal clinical trial, 1.5% of patients discontinued treatment with PROVENGE due to adverse events.¹

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.¹

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.¹

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.¹

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 have not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.¹

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.¹

Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting. PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids.

Leukapheresis is a cell-collection procedure performed at a local blood center. During a leukapheresis procedure, blood is drawn from a patient and is passed through a machine that removes a small portion of immune cells, along with some platelets and red blood cells. The machine returns the rest of the blood to the patient.

Prior to the first leukapheresis procedure, a venous assessment must be conducted by the prescribing practitioner to determine whether the patient’s veins can accommodate the procedure. If they cannot, placement of a central venous catheter (CVC) may be necessary. In IMPACT, the pivotal clinical trial for PROVENGE, 23% of patients received CVCs. ¹

Following leukapheresis, the immune cells will be sent to a Dendreon manufacturing facility to be made into a dose of PROVENGE for the patient. Once the personal dose of PROVENGE is completed, it is tranported to the patient's local infusion center and infused back into the patient.

The autologous treatment cycle occurs 2 additional times over the course of about a month.

Reference:
1. Data on file. Dendreon, LLC.