Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs

Immunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment.