Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference numberEMA/CHMP/703715/2012 Rev. 2
Published15/02/2016
Effective from01/07/2016
KeywordsNon-small cell lung cancer (NSCLC), prostate cancer, chronic myeloid leukemia (CML), myelodysplastic syndormes (MDS), haematopoietic stem cell transplantation (HSCT), breast cancer, pathologic complete response (pCR), neoadjuvant treatment, surrogate endpoint, minimal residual disease (MRD), chronic lymphocytic leukaemia (CLL)
DescriptionThis document is an appendix to the guideline on the evaluation of anticancer medicinal products in man. It provides a guidance on the clinical development for the treatment of specific conditions, including NSCLC, prostate cancer, CML, MDS and HSCT.


Document history

Revision 3

PDF iconConcept paper Published: 31/03/2017
Deadline for comments: 30/06/2017

Revision 2

Current version

PDF iconAdopted guideline In operation: 01/07/2016–present

Revision 1

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconConcept paper nr 2


PDF iconConcept paper

In operation: 01/02/2016–30/06/2016


Published: 07/10/2015


Published: 28/04/2014


Published: 31/07/2013

First version PDF iconAdopted guideline In operation: 01/07/2013–31/01/2016
Superseded document (Appendix 2)

PDF iconAdopted guideline


Overview of comments


PDF iconDraft guideline

In operation: 01/09/2010–30/06/2013


Published: 03/03/2010


Published: 19/11/2008

Superseded document PDF iconConcept paper Published: 23/01/2008

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