Challenges for the Approval of Anti-Cancer Immunotherapeutic Drugs
London, United Kingdom – 4 & 5 February 2016
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 were addressed in a workshop organised jointly by the European Medicines Agency (EMA) and the Cancer Drug Development Forum (CDDF).
This joint EMA-CDDF workshop aimed at addressing these highly relevant issues and their impact on the regulatory environment as well as discussing the challenged related to the development and approval of these medicines. The meeting provided a platform for experts from academia, oncologists, policy makers, representatives from health-technology-assessment (HTA) bodies, the pharmaceutical industry, regulatory bodies and patient organizations.
View more information
View the programme: PDF version
Download the speakers’ slides: here
View the webcast of the whole meeting: video recording available
Read some literature on this meeting:
- Press release on How to facilitate development of cancer immunotherapies
EMA website – 2 February 2016
- Press release on “Accelerating Progress in Immunotherapy”
Cancerworld, n°71 – March/April, 2016, Cutting Edge section, pg 29
- Press release on “Regulators Embrace Immunotherapy”
J. Smyth – The ASCO Post, March 25, 2016