EORTC/EMA workshop - illustration

Cancer treatment optimization research is essential for ensuring new therapies benefit both patients and healthcare providers. However, the current mechanisms for optimizing treatment post-licensing are often disorganized or non-existent, especially at the international level.

Licensing a new therapeutic intervention that is expected to bring innovation is of primary importance, but how to use these new technologies in the best interests of patients requires action in the pre-authorisation landscape as well as continued post-licensing clinical research. Licensing is simply the start of this process, but it is too often the end of it as well since treatment optimisation studies are currently voluntary. How this situation might be changed was the theme of a Cancer Medicines Forum (CMF) workshop organised by the European Medicines Agency (EMA) and EORTC on 5 April 2024, under the auspices of the EU Belgium Presidency with notable speakers from Europe, the US, and Canada.

The workshop highlighted the need for more structured and mandatory optimization studies throughout the drug development process. These studies should address key questions such as the best dosage, duration, and patient population for new treatments. Collaboration between regulatory authorities, healthcare providers, and patient organizations is crucial to making optimization research a standard part of drug approval.

Ultimately, treatment optimization aims to improve patients’ quality of life and reduce healthcare costs, making it an essential aspect of cancer care.

Disclaimer: This summary should not be understood as the official views of The EMA or its scientific committees.

For more background information about the CMF, read this publication: Saesen R et al. (2022). Advancing academia-driven treatment optimisation in oncology: launch of the EMA Cancer Medicines Forum. European Journal of Cancer. https://doi.org/10.1016/j.ejca.2022.03.025.

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