Real-World Treatment Study of Koselugo (Selumetinib) in Korean Patients with Neurofibromatosis 1 and Plexiform Neurofibroma

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, in patients with Neurofibromatosis 1 and plexiform neurofibroma who are treated in routine clinical practice settings in Korea. The study focuses on assessing known safety profiles and identifying any previously unreported adverse reactions in Korean patients. It provides valuable information about how the drug performs in real-world medical practice. Participants in this observational study are patients receiving Koselugo according to its approved label in South Korea. There are no additional treatments or interventions beyond routine care. The study gathers data over time as patients continue their usual treatment under physician supervision. This study does not involve randomization or placebo groups but monitors patients as they receive standard therapy. During the study, researchers will track adverse events and the occurrence of physeal dysplasia over one year. They will also collect physician assessments of disease status, including improvements, progression, or stability of neurofibromatosis and plexiform neurofibroma. The study involves regular monitoring and data collection during routine visits to evaluate the drug's safety and effectiveness in a real-world setting. The total duration includes follow-up for one year after enrollment.

Real-World Treatment Study of Koselugo (Selumetinib)