Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs

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TitleWorkshop on the challenges for the approval of anti-cancer immunotherapeutic drugs
Date04/02/2016 - 05/02/2016
LocationEuropean Medicines Agency, London, UK
SummaryImmunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment.

All documents

Name Language First published Last updated
Programme - Challenges for the approval of anti-cancer immunotherapeutic drugs (English only) 02/02/2016 03/02/2016
Presentation - The immunotherapy of cancer: past, present and the next frontier (Ira Mellman) - S1.1 (English only) 08/04/2016  
Presentation - The challenges of the different stakeholders: an academic perspective (Heinz Zwierzina) - S1.2 (English only) 08/04/2016  
Presentation - Challenges of anti-cancer immunotherapy development- industry perspective (Eric Rubin) - S1.3 (English only) 08/04/2016  
Presentation - Challenges for the different stakeholders: regulatory perspective (Francesco Pignatti) - S1.4 (English only) 08/04/2016  
Presentation - Lessons learnt - Melanoma: academic perspective (Paolo Ascierto) - S2.1 (English only) 08/04/2016  
Presentation - KEYTRUDA® (pembrolizumab): melanoma lessons learnt (Roger Dansey) - S2.2 (English only) 08/04/2016  
Presentation - Immunotherapies in melanoma: regulatory perspective (Jorge Camarero) - S2.3 (English only) 08/04/2016  
Presentation - Non-small cell lung cancer (NSCLC), academic perspective: lessons learnt (Enriqueta Felip) - S2.4 (English only) 08/04/2016  
Presentation - Non-small cell lung cancer (NSCLC) regulatory – industry perspective (Catherine Weil) - S2.5 (English only) 08/04/2016  
Presentation - Immunotherapies in lung cancer: regulatory perspective (Jorge Camarero) - S2.6 (English only) 08/04/2016  
Presentation - Safety – immune related adverse events (irAE) focus on non-small cell lung cancer (NSCLC) (Aaron Hansen) - S2.7 (English only) 08/04/2016  
Presentation - Biomarkers for PD-1/L1 inhibitors: regulatory considerations (Marc Theoret) - S3.1 (English only) 08/04/2016  
Presentation - Blueprint project: PD-L1 IUO assay characterization (Rasika Kalamegham) - S3.2 (English only) 08/04/2016  
Presentation - Novel biomarkers: pitfalls, limitations, emerging options (Bernard Fox) - S3.3 (English only) 08/04/2016  
Presentation - mRNA- and peptide-based anticancer immunotherapies (Michael Platten) - S4.1 (English only) 08/04/2016  
Presentation - Chimeric antigen receptor T cells charting the course from clinical trials to commercialization (Stanley Frankel) - S4.2 (English only) 08/04/2016  
Presentation - Peptides, cell therapy (Thomas Hinz) - S4.3 (English only) 08/04/2016  
Presentation - Differences between the use of immunotherapy in the adjuvant as opposed to advanced setting (Jessica Menis) - S5.1 (English only) 08/04/2016  
Presentation - Study design and analysis in late-stage cancer immunotherapy trials (Tai-Tsang Chen) - S5.2 (English only) 08/04/2016  
Presentation - CT design - combinations (Samir Khleif) - S5.3 (English only) 08/04/2016  
Presentation - How do we sequence or combine immunotherapies with targeted therapies: European perspective (Paolo Ascierto) - S5.4 (English only) 08/04/2016  
Presentation - Characterizing the contribution of monotherapy components (Ramy Ibrahim) - S5.5 (English only) 08/04/2016  
Presentation - Challenges in evaluating relative effectiveness (Mira Pavlovic) - S6.1 (English only) 08/04/2016  
Presentation - Capturing added value in immuno-oncology: balancing rapid access and new metrics for valuation (Patrick Hopkinson) - S6.2 (English only) 08/04/2016  
Presentation - Time for the European reference relative efficacy assessment (Francesco De Lorenzo) - S6.3 (English only) 08/04/2016  
Presentation - Patient reported outcomes in an era of immunotherapy drug development (David Cella) - S6.4 (English only) 08/04/2016  

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