European Guidelines for Evaluating Anticancer Medicines Updated
The European Medicines Agency has now finalised the revision of its guideline on the evaluation of anticancer medicinal products, which is due to come into effect in July 2013.
This revision is important for the pharma industry as it includes updates to guidelines on a range of highly relevant topics such as the choice of endpoints in confirmatory trials, the use of biomarkers as an integrated part of the development of medicines and combination therapy studies.
The updated guideline provides new and pertinent guidance on all stages of clinical drug development for the treatment of cancer. The goal behind the revision is to offer direction on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. Supportive measures such as anti-emetics and haematopoietic growth factors are covered by separate guidelines.
The Agency says that alongside the more traditional goals such as “defining the proper doses and schedule for a medicine”, the guideline highlights the importance of “identifying the target population during the development”. This means that the revision to the previous guidelines clarifies how biomarkers can be used during non-clinical and clinical development to help identify patients that may well have an increased chance of responding positively to treatment. In addition, the Agency highlights that confirmatory 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 confirmatory studies.
A number of questions and answers have been provided online by the CHMP Scientific Advisory Group (SAG) for Oncologyfor revision of the anticancer guideline which offers some brief insights into specific details about the updates for interested parties. Also there are two appendixes support the document and address methodological considerations for using progression-free survival in confirmatory trials, and to provide condition specific guidance for non-small cell lung cancer, prostate cancer, chronic myeloid leukaemia, myelodysplastic syndromes and haematopoietic stem cell transplantation.
The draft revision was agreed by the Agency’s Oncology Working Group back in September 2011, with consultation on the proposed changes being undertaken this time last year and the final revised guidelines confirmed for release late last week. The revision will take effect on 1 July 2013.