Generic Name and Formulations:
Sipuleucel-T (autologous CD54+ cells activated with PAP-GM-CSF); minimum 50 million cells/dose; suspension for IV infusion.
Company:
Dendreon
Indications for PROVENGE:
Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Adult Dose for PROVENGE:
Autologous use only. Obtain product release from manufacturer, match patient identity on product and Cell Product Disposition form, check expiration date and time on product before infusing. Premedicate 30 minutes before infusion with acetaminophen and antihistamine. Give three doses at 2-week intervals. For each dose: give entire contents of bag by IV infusion over 60 minutes; do not use filter; do not use if clumps do not disperse with gentle mixing. Observe patient for at least 30 minutes after infusion. May interrupt or slow infusion if acute transfusion reaction occurs; do not restart if product at room temp for >3 hours.
Children's Dose for PROVENGE:
Not applicable.
Pharmacological Class:
Autologous cellular immunotherapy.
Warnings/Precautions:
Cardiac or pulmonary conditions. Each dose requires a standard leukapheresis procedure about 3 days before infusion. If scheduled infusion is missed, do an additional leukapheresis procedure if treatment course is to be continued. Risk of disease transmission. Pregnancy, lactation: not applicable.
Interactions:
May be antagonized by concomitant chemotherapy or immunosuppressive therapy.
Adverse Reactions:
Infusion reactions (eg, chills, fever, respiratory events, GI upset, hypertension, tachycardia), fatigue, back pain, joint ache, headache.
Note:
If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).
How Supplied:
Patient-specific bag (250mL)—1
Provenge approved for the treatment of advanced prostate cancer
Dendreon announced the approval of Provenge (sipuleucel-T suspension for intravenous infusion) for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). This approval is based on three Phase 3 studies involving 737 patients submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, double blind, placebo-controlled study that eva luated men with asymptomatic or minimally symptomatic, metastatic CRPC. Provenge extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared to the control group (25.8 months versus 21.7 months). Overall, Provenge reduced the risk of death by 22.5 percent compared to the control group (HR=0.775). Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
Provenge is the first product in a new therapeutic class known as autologous cellular immunotherapies. It is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
Phase 3 study of Provenge for advanced prostate cancer
Dendreon Corporation announced results from its Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrating that Provenge (sipuleucel-T) met its primary endpoint of improving overall survival compared to placebo control in men with advanced prostate cancer. The safety profile of Provenge appeared to be consistent with prior trials.
Provenge may represent the first product in a new class of active cellular immunotherapies (ACIs), uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer.
