Provenge
| Vaccine description | |
|---|---|
| Target disease | Prostate cancer |
| Type | Protein subunit |
| Clinical data | |
| Trade names | Provenge |
| AHFS/Drugs.com | FDA Professional Drug Information |
| MedlinePlus | a611025 |
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| Routes of administration |
Intravenous |
| ATC code | |
| Legal status | |
| Legal status |
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| DrugBank | |
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Sipuleucel-T (APC8015, trade name Provenge), manufactured by Dendreon Corporation, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is a personalized treatment that works by programming each patient's immune system to seek out cancer and attack it as if it were foreign.
While referred to as a therapeutic vaccine rather than a preventive vaccine that prevents infectious disease, sipuleucel-T is instead an immunostimulant.
On February 20, 2015, Valeant Pharmaceuticals received approval to purchase all Dendreon assets (including Provenge).
The treatment cost $93,000 at FDA approval, rising to over $100,000 in 2014.
A course of treatment consists of three basic steps:
A complete sipuleucel-T treatment includes three courses at two week intervals.
Sipuleucel-T is used to treat people with metastatic, asymptomatic, hormone-refractory prostate cancer (HRPC). Other names for this stage are metastatic castrate-resistant (mCRPC) and androgen independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involvement and distal (distant) tumors; this is the lethal stage of CaP. The prostate cancer staging designation is T4,N1,M1c.
Sipuleucel-T showed overall survival (OS) benefit to patients in three double-blind randomized phase III clinical trials, D9901, D9902a, and IMPACT.
The IMPACT trial served as the basis for FDA licensing. This trial enrolled 512 patients with asymptomatic or minimally symptomatic metastatic HRPC randomized in a 2:1 ratio. The median survival time for sipuleucel-T patients was 25.8 months comparing to 21.7 months for placebo-treated patients, an increase of 4.1 months. 31.7% of treated patients survived for 36 months vs. 23.0% in the control arm. Overall survival was statistically significant (P=0.032). The longer survival without tumor shrinkage or change in progression is surprising. This may suggest the effect of an unmeasured variable. The trial was conducted pursuant to a (SPA), a set of guidelines binding trial investigators to specific agreed-upon parameters with respect to trial design, procedures and endpoints; compliance ensured overall scientific integrity and accelerated FDA approval.
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