FDA approves PROVENGE (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer

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FDA approves PROVENGE (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer

On April 29, 2010, the U.S. Food and Drug Administration approved sipuleucel-T (PROVENGE®, Dendreon Corporation), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Sipuleucel-T is a cellular immunotherapy consisting of autologous peripheral blood mononuclear cells (PBMC's), obtained by leukapheresis and cultured (activated) with a recombinant human protein (PAP-GM-CSF) consisting of prostatic acid phosphatase linked to granulocyte-macrophage colony-stimulating factor.

This approval was based on results from a randomized, double-blind, placebo-controlled, multicenter trial (Study 9902B). Overall survival (OS) was the primary efficacy endpoint of this trial. Eligible patients had metastatic disease in soft tissue and/or bone with evidence of disease progression determined at either of these sites or by serial measurement of prostate specific antigen (PSA). All patients had prior adequate hormonal therapies with castrate testosterone levels attained. Patients with visceral (liver, lung, or brain) metastases or who reported moderate to severe prostate cancer-related pain and/or use of narcotics for cancer-related pain were excluded. Patients were randomized to receive either the sipuleucel-T treatment or a control (peripheral blood mononuclear cells which were not activated). Patients in both groups underwent three leukapheresis procedures (approximately Weeks 0, 2, and 4), followed 3 days later with an infusion of either sipuleucel-T or the non-activated control. Patients who had disease progression during the trial were treated at the physician's discretion.

Five hundred twelve patients were randomized (2:1) to either sipuleucel-T (n=341) or control (n=171). Eighty-two percent had received prior combined androgen blockade, 54% local radiotherapy, 35% radical prostatectomies, 18% prior chemotherapy including docetaxel. The median age was 71 years (range 40-89); 90% were Caucasian.

Patients treated with sipuleucel-T had an improvement in median OS (25.8 months versus 21.7 months, p= 0.032, HR 0.775, 95% CI 0.61, 0.98). There was no difference in time-to- progression. Fifty-seven percent of patients in the sipuleucel-T arm and 50.3% in the control arm received docetaxel after disease progression.

A second trial (Study 9901) provided supportive evidence to the results of Study 9902B. Study 9901 was a smaller, randomized, double-blind, placebo-controlled, multicenter trial of 127 patients with metastatic, castrate resistant prostate cancer. Patients were randomized (2:1) to receive either sipuleucel-T (n = 82) or control (n = 45). The primary endpoint was time- to- disease progression. All patients were followed for OS, although the method of survival analysis was not pre-specified. Analysis of the primary endpoint did not reach statistical significance. The median OS of patients treated with sipuleucel-T was 25.9 months compared to 21.45 months for patients in the control group.

Common adverse reactions reported during a safety evaluation of 601 patients who received sipuleucel-T were chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Severe adverse events occurred in 23.6% of patients who received sipuleucel-T, compared to 25.1% of the control group. Life-threatening adverse events were observed in 4.0% of patients who received sipuleucel-T, compared to 3.3% of the control group. Fatal adverse events occurred in 3.3% of patients who received sipuleucel-T, compared to 3.6% of the control group. Serious adverse reactions that were reported more frequently in patients receiving sipuleucel-T compared with controls included acute infusion reactions and stroke.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications, is available on the FDA website.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).