Overview
- The FDA authorized selumetinib (Koselugo) for adult patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
- Approval on November 19, 2025, was supported by the phase 3 KOMET trial, which reported a confirmed overall response rate of 20% for selumetinib versus 5% for placebo.
- Among responders, 86% maintained a duration of response of at least six months in the selumetinib arm.
- Trial safety findings were consistent with the drug’s established profile from pediatric use.
- The adult authorization follows a September 2025 U.S. approval of selumetinib granules and capsules for pediatric patients aged one year and older.