Overview of cancer vaccines

Abstract

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines.

Keywords: :

• biomarker
• clinical development
• EMA
• emerging markets
• FDA
• PMDA
• regulatory
• targeted therapy
• tumor antigen

Note

The views expressed in this article are the personal views of the author and may not be understood, interpreted, or quoted as being made on behalf of, or reflecting the position of any other companies, agencies or parties cited in this article.