Workshop on first-line acute promyelocytic leukaemia treatment: European Union cooperative groups and the pharmaceutical industry
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The European Medicines Agency (EMA) is hosting a meeting with European clinical cooperative groups, the pharmaceutical industry and other regulators to discuss first-line treatment of acute promyelocytic leukaemia (APL). The topics addressed will include a historical outlook of APL treatment, recent published trials using arsenic trioxide, guidelines on clinical trials in small populations, experience with the assessment of marketing authorisation applications for rare cancers based on academic trials, benefits to patients of further product development and regulatory submissions. Registration by invitation only.