Clinical efficacy and safety: antineoplastic and immunomodulating agent guidelines

The European Medicines Agency's scientific guidelines on the clinical evaluation of antineoplastic and immunomodulating agents help medicine developers prepare marketing authorisation applications.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Evaluation of anticancer medicinal products in man
• Evaluation of anticancer medicinal products in man - addendum on paediatric oncology
• Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man - methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials
• Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man - the use of patient-reported outcome (PRO) measures in oncology studies
• Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance
• Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia
• Clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy
• Use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies
• Clinical evaluation of therapeutic radiopharmaceuticals in oncology

Reflection papers

• Guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies