title: Regulatory considerations for clinical development of cancer vaccines.
abstract: Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.
authors.affiliation: a VP (Tech) ; PAREXEL International ; The Quays , UK.
authors.forename: Bridget Theresa
authors.initials: BT
authors.lastname: Heelan
mesh_terms: D000951:Antigens, Neoplasm / Q000276:immunology*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D000951:Antigens, Neoplasm; D019496:Cancer Vaccines
keywords: AIDS, Acquired Immunodeficiency Syndrome; CAR, T-cell Chimeric Antigen Receptor T-cell; CTL-4, Cytotoxic T-lymphocyte-associated protein 4; DCs, Dendritic cells; EBV, Ebstein Barr Virus; EMA, European Medicines Agency; EU, European Union; FDA, Federal Drug Administration; HHV-8, Human Herpes Virus 8; HTA, Health Technology Assessment; ICH, International Conference on Harmonisation; ICI, Immune Checkpoint Inhibitors; ITF, Innovation Task Force; MDSC, Myeloid-derived suppressor cells; MHRA, Medicines and Healthcare products Regulatory Agency; MUC1, Membrane-bound glycoprotein MUC1 mucin; NICE, National Institute for Heath and Care excellence; OS, Overall survival; PD, Pharmacodynamic; PD-1, Programmed cell death 1; PFS, Progression-free survival; PMDA, Pharmaceutical and Medical Devices Agency; PTLD, Post-transplant lymphoproliferative disease; RECIST, Response Evaluation Criteria in Solid Tumors; Serum Igs, Serum immunoglobulins; T cells; TAA, Tumor associated antigens; TIMs, Tumor Infiltrating Myeloid Cell; Tregs, Regulatory T cells; US, United States of America; antigens; cancer vaccines; immune system; immunesurveillance; siRNA, Small interfering RNA