Thursday, Dendreon Corp. (DNDN) said that the U.S. Food and Drug Administration has approved Provenge or sipuleucel-T, an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant prostate cancer.
Provenge is designed to induce an immune response against the antigen prostatic acid phosphatase, which is expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies. Dendreon stock jumped 27% following the news on the Nasdaq.
The three Phase 3 studies involving 737 patients were submitted to FDA to support licensure. The pivotal study was the Phase 3 IMPACT or Immunotherapy for Prostate AdenoCarcinoma Treatment trial, a 512-patient, multi-center, randomized, double blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic CRPC.
Provenge extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared with 25.8 months versus 21.7 months for the control group.
Overall, the therapy reduced the risk of death by 22.5%, compared with the control group. Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
"The approval of PROVENGE, the first autologous cellular immunotherapy, represents a significant scientific and clinical advancement for the treatment of prostate cancer," said Philip Kantoff, M.D., director of the Lank Center for Genitourinary Oncology, chief of the Division of Solid Tumor Oncology, and chief clinical research officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School.
"Cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm for patients with cancer," Dr. Kantoff added.
Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.
Dendreon said that the therapy is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of the drug was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events 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 patients treated with the drug.
To fulfill a post marketing requirement and as a part of its ongoing commitment to patients, Dendreon said it will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the Provenge arm compared with 2.6% of patients in the control arm.
Dendreon said it intends to make Provenge available through approximately 50 centers, all of which were approved for the drug's clinical trial sites, and expects to increase capacity over the next year. The increased capacity will be a result of the anticipated licensure of its expanded New Jersey, Atlanta, Georgia and Orange County, Calif. facilities in mid-2011.
DRDN closed Thursday's regular trading at $50.12, up $10.50 or 26.50%, on a volume of 28 million shares on the Nasdaq. In after hours, the stock gained $10.88 or 27.46%.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.