FDA: Tumor Vaccines and Gene Therapy Products
The FDA recently issued its latest ”Development of Safe and Effective Tumor Vaccines and Gene Therapy Products” document.
Among the highlights:
*”Despite enormous efforts towards finding a cure and progress in some subsets, overall survival of cancer patients has not increased and new therapeutic approaches are warranted.”
*”Numerous investigational cancer gene therapies, tumor vaccines and immunotherapy products from industry, National Cancer Institute, and academic institutions are being reviewed at the FDA. However, to date, none of these products are in clinical use.”
*”Genomics, a novel medical technology, is being used in the characterization of cellular tumor vaccines, stem cells and cell substrates that are used to manufacture cellular and gene therapy products and also identification of cancer stem cells in head and neck and brain tumors. As genomics technology provides analysis of the total genes expressed by a sample of total RNA, it provides a unique opportunity to identify the molecular signature of whole tumor, stem cells or blood cells.”
Douglas A. McIntyre
