Personalised medicine in oncology focuses on targeting specific molecular alterations that drive cancer progression.
Tailoring care to each tumour’s molecular and genetic profile makes it possible to select treatments more likely to be effective and less likely to cause harm to non-cancerous cells.
This moves beyond traditional treatment, which often relies on broadly applied therapies.
Personalised medicine in oncology, also known as precision oncology, benefits from comprehensive genomic profiling. This practice helps identify genetic mutations and molecular alterations that may be driving tumour growth.
These insights allow clinicians to treat patients with targeted therapies or immunotherapies designed to act on those specific abnormalities.
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About one third of marketing authorisations granted in the European Union (EU) between 2010 and 2024 in the field of oncology / haematology relied on identifying patients via an in vitro diagnostic test.
In vitro diagnostics (IVDs) are key to identifying the molecular and genetic characteristics of tumours, enabling personalised treatment strategies. These characteristics are called biomarkers.
Companion diagnostics are a type of IVD that can identify those patients likely to benefit or at risk from a particular therapy. They support the safe and effective use of a specific medicinal product.
The landscape of IVDs in the EU has undergone a significant transformation with the implementation of the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746). This regulation came into full effect in May 2022.
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The European Medicines Agency (EMA) offers developers of personalised medicines in oncology several opportunities for early dialogue and consultation before submitting a marketing authorisation.
EMA's Committee for Medicinal products for Human Use (CHMP) carries out a scientific assessment of the applications and gives a recommendation on whether a medicine should be marketed or not.
Developers of personalised medicine should consult the EMA's overview template for marketing authorisation applications (section 6.3.4).
The CHMP gives a scientific opinion on the suitability of a companion diagnostic for a specific medicine. This is in line with the In Vitro Diagnostics Regulation.
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