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Dendreon Announces Presentation of PROVENGE Data at the American Society of Clinical Oncology Annual Meeting
Date:5/20/2010

of outcome and subgroup results from the integrated analysis of sipuleucel-T trials in metastatic castration resistant prostate cancer (abstract #4550)."
  • A poster presentation by Dr. Petrylak titled, "Immunotherapy survival effect persists independent of post-randomization docetaxel use in Phase 3 studies of sipuleucel-T (abstract #4551)."
  • A poster presentation by Dr. Frances P. Stewart, senior biostatician at Dendreon, titled, "Correlation between product parameters and overall survival in 3 trials of sipuleucel-T, an autologous active cellular immunotherapy for the treatment of prostate cancer (abstract #4552)."

  • PROVENGE is the first autologous cellular immunotherapy to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

    PROVENGE Safety

    PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

    The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence greater than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, 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 patie
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    SOURCE Dendreon Corporation
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