EMA opens public consultation on cancer drugs evaluation

A public consultation on the revised guideline on the evaluation of human anticancer medicines has been launched by the European Medicines Agency. 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, says the EMA. The guideline now incorporates disease-specific guidance, including new guidance for lung cancer, prostate cancer and revised guidance for hematological 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.