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

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Current effective version

Revision 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

 

Concept paperPublished: 31/03/2017
Deadline for comments: 30/06/2017

Revision 2

Current version

Adopted guidelineIn operation: 01/07/2016–present

Revision 1

 

Adopted guideline


Overview of comments


Concept paper nr 2


Concept paper

In operation: 01/02/2016–30/06/2016


Published: 07/10/2015


Published: 28/04/2014


Published: 31/07/2013

First versionAdopted guidelineIn operation: 01/07/2013–31/01/2016
Superseded document (Appendix 2)

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/09/2010–30/06/2013


Published: 03/03/2010


Published: 19/11/2008

Superseded documentConcept paperPublished: 23/01/2008

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