Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance - Scientific guideline
This 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.
Keywords: Non-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)
-
List item
Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - Condition specific guidance - Revision 1 (PDF/155.05 KB)
Adopted
First published: 07/10/2015
Last updated: 07/10/2015
EMA/CHMP/703715/2012 Rev. 1 -
List item
Overview of comments received on 'Guideline on the role of the pathological Complete Response (pCR) as an endpoint in neoadjuvant breast cancer studies' (PDF/241.81 KB)
First published: 07/10/2015
Last updated: 07/10/2015
EMA/94983/2015 -
List item
Concept paper on the need to revise condition–specific guidance, appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - Revision 1 (PDF/96.52 KB)
Draft: consultation closed
First published: 31/07/2013
Last updated: 31/07/2013
Consultation dates: 31/07/2013 to 31/10/2013
EMA/CHMP/432831/2013 -
List item
Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies (PDF/89.09 KB)
Draft: consultation closed
First published: 28/04/2014
Last updated: 28/04/2014
Consultation dates: 28/04/2014 to 31/07/2014
EMA/CHMP/151853/2014
-
List item
Appendix 2 to the Guideline on the evaluation of Anticancer Medicinal Products in Man (CPMP/EWP/205/95 Rev. 3) on Confirmatory studies in Haematological Malignancies (PDF/276.97 KB)
Adopted
First published: 03/03/2010
Last updated: 03/03/2010
EMA/CHMP/EWP/520088/2008 -
List item
Overview of comments received on draft appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 Rev.3) on confirmatory studies in haematological malignancies (PDF/472 KB)
First published: 03/03/2010
Last updated: 03/03/2010
EMA/574487/2009 -
List item
Draft appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 REV. 3) on haematological malignancies (PDF/185.34 KB)
Draft: consultation closed
First published: 20/11/2008
Last updated: 20/11/2008
EMEA/CHMP/EWP/520088/2008