PROVENGE®
Stimulate an immune response against advanced prostate cancer.
The first in a new class of therapy, PROVENGE is designed to activate a patient’s own antigen-presenting cells (APCs) to stimulate an immune response against prostate cancer.
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE Expands Your Therapeutic Options
Prior to the FDA-approval of PROVENGE, the only approved non-palliative treatment option for men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (mCRPC) was taxane-based therapy. Now, with PROVENGE you have another way to take action.
According to the NCCN Guidelines, in metastatic castrate resistant prostate cancer, “Men with less advanced (no or minimal symptoms) should consider immunotherapy with PROVENGE; men who are symptomatic should be considered for chemotherapy.”1
- PROVENGE is the first FDA-approved autologous cellular immunotherapy
- PROVENGE extends median survival beyond 2 years, in men with asymptomatic or minimally symptomatic mCRPC
- PROVENGE therapy is completed in about a month
- The most common adverse events are primarily mild or moderate
PROVENGE does not preclude use of subsequent therapies.
- In the Phase 3 IMPACT Trial, 81.8% of patients in the PROVENGE group received additional anticancer treatments2
Next: Learn About PROVENGE
References
- NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. V.4.2011. National Comprehensive Cancer network.
- Kantoff PW, Higano CS, Shore ND, et al for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castrate-resistant prostate cancer. N Engl J Medicine 2010;363(5):411-422.
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 include 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 are chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Please see the Full Prescribing Information.