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Spanish regulators review European regulatory landscape for cancer vaccines | BioQuality.biz

Cancer immunotherapy products: Regulatory aspects in the European Union.

Hum Vaccin Immunother. 2012 Sep 1;8(9). [Epub ahead of print], Camarero J, Ruiz S., Spanish Medicines Agency; Pharmacology and Clinical Assessment Division; Madrid, Spain.


  • Cancer vaccines, also known as active immunotherapy products are products whose mode of action is to evoke an immune response designed to cause tumor destruction or at least reduce the progression of the tumor.
  • The nature of these products results in certain challenges and difficulties:
    • Quality attributes of these products can be difficult to characterize
    • There is typically a high variability in measurement of quality and other attributes
    • This is especially so for autologous therapies
    • The above complicate interpretation of clinical data
  • Another difficulty according to the authors are the “questions arise in the evaluation of efficacy and safety data in comparison with current chemical or biological treatments for the same indications.”
  •  This review explores the European Union regulatory requirements for such products
  •  Two products, both of which are considered therapeutic cancer vaccines, recently assessed by the regulators are used as examples: Oncophage, for renal cell carcinoma and Provenge, for prostate cancer

To see the Abstract, and a link to obtain this paper: http://www.ncbi.nlm.nih.gov/pubmed/22863755

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