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

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