How to facilitate development of cancer immunotherapies

News 02/02/2016

Watch live broadcast of expert discussion at EMA

A workshop on the challenges for the approval of immunotherapy medicines for cancer will take place at the European Medicines Agency (EMA) on Thursday and Friday, 4-5 February 2016. The workshop is organised jointly by EMA and the Cancer Drug Development Forum (CDDF).

You can follow a live broadcast of the workshop by clicking on the 'multimedia' tab on the event page.

Immunotherapy is a fast growing area of new medicines in oncology. A new type of immunotherapy to fight cancer cells was approved for the first time in the European Union (EU) in 2015. These medicines target 'suppressive signals' that prevent the development of an immune response, thereby enhancing the immune system to help fight cancer. These new medicines have significantly changed the therapeutic landscape and have increasingly benefited patients with some cancers, e.g., lung cancer and melanoma.

However, there are still many challenges related to bringing cancer immunotherapies through the regulatory approval process and into clinical practice. This joint EMA-CDDF workshop will provide a platform for experts from academia, oncologists, policy makers, representatives from health-technology-assessment (HTA) bodies, the pharmaceutical industry, regulatory bodies and patient organisations to discuss the challenges related to the development and approval of these medicines. In particular, experts will discuss appropriate patient population selection, new clinical trial designs, the rationale for the mechanism of action in different tumour types, innovative immunological-based products used in combination, and assessment of relative efficacy of these novel medicines.

For more information, please see the PDF icon agenda of the workshop.

Presentations and a video recording of the event will be published after the workshop.

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