Plexiform neurofibromas (PNF) can cause disfigurement, pain and neurological deficits. For children with PNF that cannot be removed by surgery, there are no authorized treatment options. Selumetinib has been shown to be effective at shrinking PNF size in children aged 3 years and older. Although data on safety were limited, they indicate that the side effects of Selumetinib are manageable. The European Medicines Agency therefore decided that Selumetinib’s benefits are greater than its risks and it can be authorized for use in the EU.
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