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EMA rules for cancer drugs
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EMA rules for cancer drugs

15.01.2013 - The European Medicines Agency has updated guidelines on cancer drugs in clinical development.

„Convincingly demonstrated favourable effects on overall survival (OS) are from both a clinical and methodological perspective, the most persuasive outcome of a clinical trial“, the London-based Agency writes in its new guidelines that will come into force this July. However, prolonged progression-free or disease-free survival will be, in most cases, be considered relevant measures of patients benefit, but the magnitude of the treatment effect has to be sufficiently large to outbalance toxicity and tolerability problems.

Alongside conventional aims such as defining the proper doses and schedule for a medicine, the guideline highlights the importance of identifying the target population during the development. With regard to the co-development of stratification biomarkers, personalised medicine has become reality. The new guidance document covers the use of biomarkers as an integrated part of drug development. This means that in most cases, hypotheses are to be tested and confirmed with appropriate candidate biomarkers through all phases of clinical development. In cancer indication the Agency sees a substantial need for biomarker tests whereas in other indications they might be more „informative“.

Confirmation trials should demonstrate that the investigational product provides clinical benefit. From both a clinical and a methodological perspective, the most persuasive outcome of a clinical trial is the demonstration of favourable effects on overall survival. Prolonged progression-free survival and disease-free survival are also considered to be of benefit to the patient. The guideline describes how to select the appropriate endpoints for confirmation studies.

Two appendixes complement the guideline, to address methodological considerations for using progression-free survival in confirmatory trials, and to provide condition specific guidance for non-small cell lung cancer (NSCLC), prostate cancer, chronic myeloid leukaemia (CML), myelodysplastic syndromes, and haematopoietic stem cell transplantation.

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