Article Abstract

The changing world of cancer drug development: the regulatory bodies’ perspective

Authors: Iordanis Gravanis, Camille Vleminckx, Bertil Jonsson, Francesco Pignatti


Background: Although not a singular disease entity, advanced cancer continues to be a largely intractable disease and a high unmet medical need situation. Discovery of novel therapeutic modalities, including new drugs targeting cancer, is undoubtedly of major public health interest.
Methods: In this article, we discuss current trends in oncology drug development as these are ultimately reflected in regulatory drug approvals.
Results and conclusions: These include the shift to targeted therapies which hold the promise of personalized medicine, but also financial pressures, the call for adaptive licensing which places more emphasis on early access and post-authorization studies (patient registries, prospective interventional and observational studies) and real-life effectiveness studies, as well as the emergence of biosimilars in the oncology treatment armamentarium.