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Selumetinib (Koselugo) is the first medicine for children and adults with neurofibromatosis type 1 whose plexiform neurofibromas, benign but disfiguring and painful nerve tumours, cannot be removed by surgery.
Selumetinib was approved by the FDA in April 2020 for children aged 2 and over with NF1 and symptomatic, inoperable plexiform neurofibromas, on the SPRINT phase 2 stratum 1 trial in which two-thirds of 50 children had a confirmed partial response with improvements in pain and function; approval was extended to adults (KOMET trial) and, with a granule formulation, to children from 1 year in 2025. The EU granted conditional authorisation in 2021. Plexiform neurofibromas are benign tumours, but the drug is an oncology-class MEK inhibitor developed with Merck & Co. Rash, paronychia, diarrhoea, raised creatine kinase, reduced ejection fraction and ocular toxicity are class effects and require monitoring. Mirdametinib (Gomekli, 2025) is the second MEK inhibitor for the same condition.
Non-ATP-competitive inhibitor of MEK1 and MEK2; in NF1-deficient cells with unrestrained RAS activity it lowers ERK signalling and shrinks plexiform neurofibromas. Connects to MEK1/2.
1.Selumetinib slips into a pocket on MEK1/2.
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| Region | Year | Indication |
|---|---|---|
| US | 2020 | NF1 with symptomatic, inoperable plexiform neurofibromas, children 2 and over (extended to adults and to age 1 and over in 2025) |
| EU | 2021 | Symptomatic, inoperable plexiform neurofibromas in NF1, children 3 and over (conditional) |
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Query for this drug: (TITLE:"Selumetinib" OR ABSTRACT:"Selumetinib" OR TITLE:"Koselugo" OR ABSTRACT:"Koselugo") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Selumetinib, not a curated reading list.
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