Paediatric Strategy Forums have been created by the multistakeholder organisation, ACCELERATE, and the European Medicines Agency to facilitate dialogue between all relevant stakeholders and suggest strategies in critical areas of paediatric oncology drug development. As there are many medicines being developed for B-cell malignancies in adults but comparatively few in children with these malignancies, a Paediatric Strategy Forum was held to discuss the best approach to develop these products for children. It was concluded that as current frontline therapy is highly successful, despite associated acute toxicity, de-escalation of this or substitution of presently used drugs with new medicines can only be undertaken when there is an effective salvage regimen, which is currently not available. Therefore priority should be given to developing treatment for patients with relapsed and refractory mature B-cell lymphomas. The consensus of the clinicians attending the meeting was that CAR T-cells, T-cell engagers and antibody drug conjugates (excluding those with a vinca alkaloid-like drug) presently have the greatest probability of providing benefit in relapse in view of their mechanism of action. However, as producing autologous CAR T-cells currently takes at least 4 weeks, they are not products which could be quickly employed initially at relapse in rapidly progressing mature B-cell malignancies but only for the consolidation phase of the treatment. Global, industry-supported, academic-sponsored studies testing compounds from different pharmaceutical companies simultaneously should be considered in rare populations, and it was proposed that an international working group be formed to develop an overarching clinical trials strategy for these disease groups. Future Forums are planned for other relevant paediatric oncologic diseases with a high unmet medical need and relevant molecular targets.

AbbVie Limited North Chicago IL USA

ACCELERATE

Acerta Pharma SF USA

Amgen Research Munich Germany

ANSM Saint Denis France

Bayer Healthcare NJ USA

Celgene Corporation NJ USA

Centre for Cancer and Immunology Research Children's National Health System The George Washington University Washington DC USA

Centre for Therapeutic Innovation in Oncology Servier France

Centrer for Global Health NCI NIH USA

Children's Cause for Cancer Advocacy Washington DC USA

Children's Hospital of Philadelphia PA USA

Christian Albrechts Universität Kiel Germany

Clinical Development Kite Pharma CA USA

Debiopharm International SA Lausanne Switzerland

Department of Clinical Research Gustave Roussy Paris Sud University Paris France

Department of Paediatric Haematology and Oncology Addenbrooke's Hospital Cambridge UK

Department of Paediatric Hematology and Oncology Oslo University Hospital Norway

Gilead Sciences International Limited Cambridge UK

HCA Healthcare London UK

Hoffman La Roche Limited Basel Switzerland

Institute Gustave Roussy France

Janssen Research and Development NJ USA

Merck and Co Inc Kenilworth NJ USA

Novartis NJ USA

Office of Hematology and Oncology Products U S Food and Drug Administration MD USA

Oncology Clinical Development Bristol Myers Squibb Pharma EEIG NJ USA

Paediatric Drug Development Children and Young People's Unit The Royal Marsden NHS Foundation Trust London UK; Divisions of Clinical Studies and Cancer Therapeutics The Institute of Cancer Research London UK

Paediatric Medicines Office Product Development Scientific Support Department European Medicines Agency London UK

Paediatric Oncology Reference Team UK

Pediatric Hematology Oncology and BMT University Hospital Münster Germany

Pediatric Oncology Department University Hospital Brno School of Medicine Masaryk University Brno Regional Centre for Applied Molecular Oncology Masaryk Memorial Cancer Institute ICRC Brno St Anna University Hospital Brno Czech Republic

Unite2cure UK

Universitair Ziekenhuis Antwerpen Belgium

Universitätsklinikum Schleswig Holstein Kiel Germany

University of Utah Department of Pathology Salt Lake City UT USA

Wolfson Childhood Cancer Research Centre Northern Institute for Cancer Research Newcastle University UK

Zoé4life Switzerland

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