In September 2025, Spain’s national medicines agency, AEMPS, announced a significant regulatory change: the expansion of its fast-track assessment procedure to include early-phase clinical trials in oncology and rare diseases.1 This reform shortens evaluation timelines to just 26 days in eligible cases, nearly halving the traditional approval window. For paediatric oncology, this opens the door for children with aggressive, treatment-resistant cancers to access innovative therapies more quickly, at a stage when each week can be decisive.

Paediatric cancer remains a rare but devastating diagnosis, affecting roughly 1,100–1,200 children and adolescents (0–18 years old) annually in Spain.2 Despite remarkable progress in treating diseases such as acute lymphoblastic leukaemia (ALL), which now sees survival rates above 80%,3 outcomes for other paediatric tumours such as high-grade gliomas, metastatic sarcomas or various relapsed/refractory tumours remain dismally low.