Consultation launched on the revised guideline on the evaluation of human anticancer medicines

The European Medicines Agency launches a public consultation aimed at evaluating the revised guideline which provide advices and information on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds.

The European Medicines Agency has launched a public consultation on the revised guideline on the evaluation of human anticancer medicines. Comments on the reflection paper should be submitted by 31 May 2012 using the Agency’s comments template provided at its website. Recently, the European Medicines Agency has also announced that had introduced a simplified process for SME register.

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

In addition, the revision includes the appendix on methodological considerations for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials which has also been extended, in particular aspects related to censoring, radiological review, interim analyses and cross-over.