Workshop on site and histology - Independent indications in oncology
Date:
14/12/2017 to 15/12/2017
Location:
European Medicines Agency, London, UK
Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.
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Agenda - Workshop on site and histology - Independent indications in oncology (PDF/307.75 KB)
First published: 30/11/2017
Last updated: 14/12/2017
EMA/CHMP/673240/2017 -
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Registration form - Workshop on site and histology - Independent indications in oncology (PDF/77.74 KB)
First published: 20/11/2017
Last updated: 20/11/2017
EMA/743635/2017 -
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Presentation - Session 1: Definition of a driver. Cellular/tissular mechanisms supporting that a driver becomes a target multiple drivers, mechanisms of resistance (Christian Rolfo) (PDF/7.03 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 1: Non-clinical models: tumour models - proof of concept (Edward Rosfjord) (PDF/6.23 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 1: Nonclinical Models: proof of concept (Jan Willem van der Laan) (PDF/276.57 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 2: Parameters guiding a site/histology - independent drug development (Jan Schellens) (PDF/4.65 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 2: The BRAF story (Yibing Yan) (PDF/979.16 KB)
First published: 07/02/2018
Last updated: 14/02/2018 -
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Presentation - Session 3: How could molecular profiling impact histology independent labels in the future? (Marlene Thomas) (PDF/788.3 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 3: Designs for basket clinical trials and the exploratory/confirmatory paradigm (Richard Simon) (PDF/1.66 MB)
First published: 07/02/2018
Last updated: 20/02/2018 -
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Presentation - Session 4: What defines the disease and populations? How to deal with large subgroups within an indication? Heterogeneity, lack of historical real-life data, rarest subtype (Jan Bogaerts) (PDF/499.04 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 4: Statistical considerations for the development of diagnostic tests (Olivier Collignon) (PDF/196.15 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 4: Accuracy of diagnostic methods and impact on clinical management : the lymphopath network experience (Philippe Gaulard) (PDF/1.17 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 4: What have we learnt from the anti PD1- PDL1 story? (Jorge Camarero ) (PDF/1.56 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 5: Design concept for a confirmatory basket trial (Robert Beckman) (PDF/797.43 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 5: Post-approval confirmatory/supplementary data: registries and observational trials (Vincent Ho) (PDF/1.51 MB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 5: Approval of pembrolizumab (MSI-H/dMMR) and considerations for site-agnostic development of drugs in oncology (Steven Lemery) (PDF/720.17 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 5: Considerations in development of pembrolizumab in msi-h cancers (Christine Gause) (PDF/884.63 KB)
First published: 07/02/2018
Last updated: 07/02/2018 -
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Presentation - Session 5: Histology independent indications - the HTA view (Anja Schiel) (PDF/251.91 KB)
First published: 07/02/2018
Last updated: 07/02/2018