Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science.

The landscape of drug development has evolved with the adoption of new therapeutic modalities, cutting-edge technology platforms, emerging scientific insights, and modern patient-centric clinical trial designs. In this review, we investigate the interplay between innovation and regulatory science in cancer drug development in the United States. As new innovations emerge, regulatory science adapts to integrate new discoveries and technologies, ensuring alignment with established regulations and safety standards. This fuels additional innovations through data and evidence generation, potentially expediting the development of revolutionary treatments and advancing patient access to novel, promising therapies. Early and frequent engagement with regulators is vital for drug developers aiming to successfully apply innovative approaches.