For decades, scientists have tried to prove that the immune system can be harnessed to fight cancer. For Dendreon and our dedicated collaborators in the medical community, it has been a 15-year journey that has involved more than a thousand courageous patients, 15 clinical trials, and nearly one billion dollars of funding of research and development.
With every step of this journey, patients have been our inspiration, and the FDA approval of PROVENGE® (sipuleucel-T) is just the beginning.
The approval by the US Food and Drug Administration of PROVENGE marks a new era in personalized medicine: one in which each dose of treatment is manufactured using a patient’s own live cells to target his prostate cancer.
We are proud to be able to provide PROVENGE to approximately 2,000 patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer within the first 12 months. This is an important step toward realizing our mission of transforming the lives of patients with cancer, but it is not enough.
We recognize that we have a unique challenge. Given the personalized approach we discovered with autologous cellular immunotherapy, coupled with the number of eligible patients, we expect that the demand for PROVENGE will exceed our ability to manufacture it, at first. That’s why we are in the process of expanding our manufacturing capacity over the next 12 months.
So our commitment is this: we will continue to build, continue to invest, and continue to do everything we can to make sure PROVENGE will be available to the many patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer who may benefit from it.
At Dendreon, so many of us have been affected by cancer, which is why we have dedicated our lives to transforming the way cancer is treated. And for all of us, this is just the beginning.
With Gratitude,
Mitchell H. Gold, MD â—Ź President and Chief Executive Officer
INDICATION AND IMPORTANT SAFETY INFORMATION:
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
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.
For more information on PROVENGE, please visit: www.PROVENGE.com.
Please see full Prescribing Information or call Dendreon ON Call at 1-877-336-3736.
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