Addressing challenges of innovative cancer immunotherapy medicines

News 16/08/2016

EMA workshop to discuss treatments based on genetically modified T-cells

The European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) is organising a workshop on 15 and 16 November 2016 to discuss scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that normally fight off viruses and bacteria).

Immunotherapy is a type of cancer treatment that mobilises the body's own defence mechanisms to fight cancer. Immunotherapy medicines have significantly changed the therapeutic landscape, particularly for the treatment of patients with certain cancers, such as lung cancer or melanoma.

T-cell based immunotherapy is an innovative approach where T cells from a patient's blood are genetically engineered in a laboratory in order to allow them to recognise cancer cells through specific receptor proteins. In the body of a patient, the modified T-cells can then identify and destroy cancer cells.

T-cell immunotherapy medicines are being developed and are currently being tested in clinical trials in a variety of cancers. However, there are still many scientific and regulatory challenges to be overcome before these innovative products can be brought to the market for the benefit of patients.

Therefore the open workshop aims to facilitate dialogue between the CAT and medicine developers from industry and academia on:

  • current scientific developments;
  • regulatory requirements for product manufacture and testing;
  • non-clinical studies and clinical development.

The PDF icon programme of the workshop is available. The event will be broadcast live.

People interested in participating are invited to register. As places are limited, participants are advised to register early.

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