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Sipuleucel-T (Provenge), The First FDA-Approved Cancer “Vaccine” – What Every Medical Student Should Know

Posted by medliorator on May 4, 2010

Here are the bare bones facts on Provenge. A basic understanding will help you to stand out when the discussion inevitably comes up.

Drug Name: Sipuleucel-T
Trade Name: Provenge
Trial Name: APC 8015
Manufacturer: Dendreon Corporation
Class: autologous, dendritic cell-based immunotherapy
Indication: hormone-refractory, metastatic prostate cancer
MOA: Induces patient’s own cells to attack prostate cancer.
MOA (detailed): Patient’s immune cells are collected by leukapheresis and sent to a Dendreon facility approximately 3 days prior to treatment. Immune cells are exposed to  recombinant protein (known as PA 2024) that has two, fused components: (1) a prostate cancer associated antigen called prostatic acid phosphatase (PAP) that is expressed in ~95% of prostate cancers and (2) granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator.  After PA 2024 exposure and processing, the activated cells are infused back into the patient, divided into in three doses two weeks apart.
SFX: f/c, fatigue, back pain, nausea,joint ache, HA.
Cost: $93,000 per treatment
Efficacy: Extends men’s lives by an average of 4.1 months (based upon IMPACT trial D9902B, a 512-patient RTC).
Misconceptions: Provenge differs from traditional vaccines in that it does NOT prevent cancer. “Immunotherapy” is perhaps a better substitute for the term, “vaccine.”

Further reading…
FDA approves prostate cancer “vaccine” [BMJ]
Current status of immunological therapies for prostate cancer [Curr Opin Urol]

Posted in Oncology, Pharmacology, Urology | Comments Off on Sipuleucel-T (Provenge), The First FDA-Approved Cancer “Vaccine” – What Every Medical Student Should Know