Evolution of the Regulatory Landscape for Immunomodulatory Compounds and Personalized Therapeutic Cancer Vaccines

The term cancer immunotherapy covers a huge range of different therapeutic interventions based on highly diverse medicinal products. Some immunotherapy products such as monoclonal antibodies have successfully been developed during the last years and contributed to major advances in cancer therapy. Development of cancer vaccines seemed to be more challenging. Nevertheless, some promising candidates are currently in late-stage clinical development, and one product (sipuleucel-T) was recently approved in the United States (USA) and in the European Union (EU). Additionally, cell therapy approaches based on adoptive lymphocyte transfer have recently come into focus due to surprisingly efficient antitumor effects on one side and a comparably good safety profile on the other. Here, we briefly summarize the regulatory classification of immunotherapy approaches. The second part focuses on the evolving regulatory landscape for nonpersonalized and personalized cancer vaccines that have been in the focus of the CIMT regulatory research group during the last years.