Sipuleucel-T

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Sipuleucel-T
Clinical data
Trade namesProvenge
Other namesAPC8015
AHFS/Drugs.comMicromedex Detailed Consumer Information
MedlinePlusa611025
License data
Pregnancy
category
  • N/A (only approved in men, prostate cancer)
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
 ☒NcheckY (what is this?)  (verify)

Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP).[1][3][4] It is an autologous cellular immunotherapy.[1]

Medical uses

Sipuleucel-T is indicated for the treatment of

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.[5][6][7]

Treatment method

A course of treatment consists of three basic steps:

Premedication with acetaminophen and antihistamine is recommended to minimize side effects.[8]

Side effects

Common side effects include: bladder pain; bloating or swelling of the face, arms, hands, lower legs, or feet; bloody or cloudy urine; body aches or pain; chest pain; chills; confusion; cough; diarrhea; difficult, burning, or painful urination; difficulty with breathing; difficulty with speaking up to inability to speak; double vision; sleeplessness; and inability to move the arms, legs, or facial muscles.[9][10]

Society and culture

Legal status

Sipuleucel-T was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic HRPC.[11][12][2][13][1]

Shortly afterward, sipuleucel-T was added to the compendium of cancer treatments published by the National Comprehensive Cancer Network (NCCN) as a "category 1" (highest recommendation) treatment for HRPC. The NCCN Compendium is used by Medicare and major health care insurance providers to decide whether a treatment should be reimbursed.[14][15]

Research

Clinical trials

Completed

Sipuleucel-T showed

phase III clinical trials, D9901,[6] D9902a,[16][17] and IMPACT.[5]

The IMPACT trial

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.[7] The trial was conducted pursuant to a FDA Special Protocol Assessment (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.[citation needed
]

The D9901 trial

statistically significant (P=0.01).[citation needed
]

The D9902a trial[16] was designed like the D9901 trial but enrolled 98 patients. The median survival time for patients treated with sipuleucel-T was 19.0 months comparing to 15.3 months for placebo-treated patients, but did not reach statistical significance.[citation needed]

Ongoing

As of August 2014, the PRO Treatment and Early Cancer Treatment (PROTECT) trial, a phase IIIB clinical trial started in 2001, was tracking subjects but no longer enrolling new subjects.

HIFU) for curative intent. Such failure is called biochemical failure and is defined as a PSA reading of 2.0 ng/mL above nadir (the lowest reading taken post primary treatment).[21]

As of August 2014, a clinical trial administering sipuleucel-T in conjunction with ipilimumab (Yervoy) was tracking subjects but no longer enrolling new subjects; the trial evaluates the clinical safety and anti-cancer effects (quantified in PSA, radiographic and T cell response) of the combination therapy in patients with advanced prostate cancer.[22]

References

  1. ^ a b c d "Provenge- sipuleucel-t injection". DailyMed. Retrieved 22 July 2021.
  2. ^ a b "Provenge (sipuleucel-T)". U.S. Food and Drug Administration. 22 July 2017. Retrieved 1 April 2020.
  3. S2CID 209171318
    .
  4. ^ Immunostimulatory composition
  5. ^
    PMID 20818862
    .
  6. ^
    PMID 16809734
    .
  7. ^
    PMID 20818868
    .
  8. PMID 20818862
    .
  9. ^ "Sipuleucel-T (Intravenous Route) - Side Effects". Mayo Clinic. Retrieved 22 April 2015.
  10. U.S. Food and Drug Administration
    (FDA). Retrieved 22 April 2015.
  11. ^ Richwine L (29 April 2010). "U.S. FDA OKs Dendreon's prostate cancer vaccine". Reuters. Retrieved 30 April 2010.
  12. ^ "Approval Letter - Provenge". Food and Drug Administration. 29 April 2010.
  13. ^ "Provenge (sipuleucel-T)". U.S. Food and Drug Administration. 14 July 2017. Archived from the original on 22 July 2017. Retrieved 1 April 2020.{{cite web}}: CS1 maint: unfit URL (link)
  14. ^ "NCCN Guidelines and NCCN Compendium Updated". Retrieved 8 January 2011.
  15. ^ "NCCN Drugs & Biologics Compendium".
  16. ^ a b Higano C, Burch P, Small E, Schellhammer P, Lemon R, Verjee S, Hershberg R (October 2005). Immunotherapy (APC8015) for androgen independent prostate cancer (AIPC): final progression and survival data from a second Phase 3 trial. 13th European Cancer Conference. Paris.
  17. ^ Mason K (2 November 2005). "New treatment options for patients with prostate cancer". ECCO-the European CanCer Organisation.
  18. ISBN 978-1-63321-687-7. Archived from the original
    on 26 June 2015. Retrieved 20 July 2014.
  19. PMID 20818862
    .
  20. ^ "NCT00779402: Provenge for the Treatment of Hormone Sensitive Prostate Cancer". ClinicalTrials.gov. US National Institutes of Health. 29 June 2017.
  21. PMID 16798415
    .
  22. ^ "Sipuleucel-T and ipilimumab clinical trials". ClinicalTrials.gov. US National Institutes of Health. 23 August 2017.

Public Domain This article incorporates

U.S. National Cancer Institute
.

Further reading

External links

  • "Sipuleucel-T". Drug Information Portal. U.S. National Library of Medicine.
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