Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1

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.

NCT Number	NCT07024394
Lead Sponsor	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions	Neurofibromatosis 1, Plexiform Neurofibroma, NF1
Enrollment	65 participants
Start Date	2025-06-12
Primary Completion	2029-09-23 (estimated)
Study Completion	2029-09-23 (estimated)
Updated on ClinicalTrials.gov	2025-06-17