Abstract
BACKGROUND/AIMS: Precision medicine has only been a clinical reality only since the start of the 21st century, spurred on by the coevolution of science and technologies, as well as the increasing medical needs of aging societies of industrialized countries. Its overarching objective, from the perspective of the pharmaceutical and diagnostic industry, is to develop innovative therapeutic "concepts" with increased value for patients in a global health economy context. This article analyzes the recent advances and remaining challenges from a research, medical, and regulatory perspective in the development and introduction of precision medicine in oncology, more precisely in immuno-oncology. METHODS: Analysis of the most recent scientific publications and clinical evidence. RESULTS AND CONCLUSION: Stakeholders need to combine efforts in order to turn scientific insights, such as those related to predictive biomarkers, into superior and affordable therapeutic concepts. Policymakers should also help to bring this about by ensuring that a suitable regulatory framework and incentive system are in place in order to encourage groundbreaking innovation, and hence the availability of new treatment options for patients.