2023-11-22 08:00:00
FDA Approves Bosutinib as First-Line Treatment for Children with CML
In a significant development for the treatment of chronic myelogenous leukemia (CML) in children, the Food and Drug Administration (FDA) has granted approval for the use of bosutinib as the first treatment option for pediatric patients in the United States. This marks a major milestone in the fight against the rare form of blood cancer, which affects several children in the Netherlands each year.
The approval comes after a clinical study led by Michel Zwaan at the Princess Máxima Center and the Erasmus MC showed promising results for the use of bosutinib in children with CML. The study, which involved 60 children from 67 hospitals in Europe and the US, found that the effectiveness of bosutinib is comparable to other medications approved for pediatric CML patients. Importantly, the study also revealed that bosutinib had fewer side effects on bone growth, a critical consideration for children undergoing cancer treatment.
According to Zwaan, the side effects of bosutinib were found to be predominantly related to stomach and intestinal complaints, with muscle and bone pain being much less common compared to current medications for CML. However, he stressed the need for further research to monitor the long-term impact of the medication on bone growth in children.
The study, which began in 2016 at Erasmus MC and later moved to the Princess Máxima Center, was funded by pharmaceutical company Pfizer. The Trial and Data Center at the Máxima played a key role in designing and coordinating the study, which also involved collaboration with the Children’s Oncology Group in the United States.
While the approval in the United States is a significant step forward, it is not yet known when bosutinib will become available in the Netherlands. The data from the clinical study will be presented to the European Medicines Agency (EMA) in the first quarter of 2024, with the hope that the medication will soon be accessible to children with CML in the country.
The approval of bosutinib as a first-line treatment for children with CML represents a significant advancement in the field of pediatric oncology, offering new hope for young patients and their families. Further research and continued monitoring will be essential to fully understand the potential benefits of bosutinib in improving the quality of life for children battling this rare form of leukemia.]
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