FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.
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Single group
Luvometinib Tablets
Drug5mg/m² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, until disease progression or study completion, whichever occurs first
long term safty
Adverse events during treatment of FCN-159 will be assessed by the investigators according to CTCAE 5.0.
Height in centimeters
Height will be measured in centimeters, with subsequent plotting of height growth curves and calculation of growth velocity.
Weight in kilograms
Weight will be measured in kilograms, with subsequent plotting of weight growth curves.
Tanner stage
Tanner stage will be examined, and the mean age for each Tanner stage will be calculated.
Progression-Free Survival (PFS)
PFS assessed per REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) criteria by inverstigator
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