Regulatory Landscapes in Approval of Cancer Vaccines

Abstract

Cancer vaccines are hypothesized to trigger an immunological reaction against cancerous tissues. The scope of expanded clinical activities in the cancer vaccine research programmes can be acknowledged by the fact that around 2000 trials are registered under clinical cancer vaccines programme. The research activities in the cancer vaccine research area have gained a boost following the marketing authorization of Sipuleucel-T—the very first cancer vaccine in the US and EU. Though the regulatory guidelines for already existing cancer therapies like chemotherapy, radiotherapy are well established. Recently, the guidelines regarding regulatory aspects for cancer vaccines are developed. However, these guidelines are advisory in nature about the clinical requirements. However, the cancer vaccine development is relatively new area of research. There exists a huge scope for innovative strategies in this field. Hence, bilateral talks with the regulatory body are mandatory requirement to discuss and deliberate the clinical development plan on case-by-case basis. Thereby, the specific issues related to the quality of product under development are taken into consideration. All such regulatory aspects pertaining to the development and approval of cancer vaccines are discussed hereby in this chapter.