Observational Study on Safety and Effectiveness of Koselugo Selumetinib in Korean Patients with Neurofibromatosis 1 and Plexiform Neurofibroma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Koselugo Selumetinib, an oral selective inhibitor of MAPK kinase MEK 1 and 2, in patients treated in routine clinical practice settings in Korea. This study aims to characterize the known safety profile, identify any previously unknown adverse reactions, and assess treatment effectiveness in the Korean patient population with Neurofibromatosis 1 and plexiform neurofibroma. The study observes patients who are currently treated with Koselugo according to the approved label in South Korea. Since this is an observational study, there are no assigned interventions or treatments beyond routine medical care. Researchers will monitor patients over time to gather real-world data on treatment outcomes and safety. Participants will be followed for at least one year, during which adverse events and the occurrence of physeal dysplasia will be recorded. Physicians will also provide qualitative assessments of disease status, noting improvement, progression, or stability of Neurofibromatosis 1 and clinically significant plexiform neurofibromas. The study provides ongoing safety and effectiveness information without altering usual care.

Real-World Treatment Study of Koselugo (Selumetinib)