Public consultation opens on the revised guideline on the evaluation of human anticancer medicines

The European Medicines Agency has launched a public consultation on the revised guideline on the evaluation of human anticancer medicines. The purpose of the guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds.

The revised guideline underlines the importance of exploratory studies in order to properly define the most appropriate target population and puts further emphasis on the role of biomarkers. The guideline now incorporates disease-specific guidance, including new guidance for lung cancer, prostate cancer and revised guidance for haematological malignancies.

The appendix on methodological considerations for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials has also been revised and expanded, in particular aspects related to censoring, radiological review, interim analyses and cross-over.

Comments on the reflection paper should be submitted by 31 May 2012 using the Agency's comments template