059 Trial of Inotuzumab Ozogamicin
The European Medicines Agency has approved inotuzumab ozogamicin for children with high-risk acute lymphoblastic leukemia (ALL) following successful clinical trials. The drug, previously available only for adults, showed that 75% of children in the study remained cancer-free.
Why it matters
This approval provides a critical new treatment option for pediatric patients with relapsed leukemia, marking a significant advancement in childhood cancer care.
Prinses Máxima Centrum voor kinderoncologie (Princess Máxima Center) shared on LinkedIn :
“ The targeted drug inotuzumab ozogamicin has been approved for children with acute lymphoblastic leukemia (ALL).
The decision was made earlier this year by the European Medicines Agency (EMA) , which evaluates and approves medicines for use in the European Union. The approval is based in part on impressive results from a clinical trial investigating the drug, led by the Princess Máxima Center: three quarters of children were cancer free .
Results from a high-risk group of patients enrolled in the study were published last month in the leading journal The Lancet Haematology .
Acute lymphoblastic leukemia (ALL) is the most common form of childhood cancer .
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