Cancer Vaccines: Clinical Development Challenges and Proposed Regulatory Approaches for Patient Access to Promising Treatments.

In this article, the authors discuss three potential regulatory solutions to better enable the development and commercialization of therapeutic cancer vaccines. The solutions include a proposed cost-recovery program from the U.S. Food and Drug Administration, conditional marketing authorization and a development paradigm. According to the authors, the solutions aim to balance a complex equation of biologic rationale, weight of the evidence for efficacy and safety, regulatory expectations, and cost and timeline of clinical development.