Koselugo司美替尼 selumetinib

Drug Class

MEK1/2 inhibitor

Mechanism

Selumetinib is a selective inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2), blocking downstream RAF-MEK-ERK signaling pathway activation in cells with NF1 mutation.

Approved Indication

Treatment of pediatric patients 1 year and older and adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

What This Means For Patients

Koselugo司美替尼 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2020) — Sources
• EMA — Approved (2021) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

• SPRINT — Gross et al., N Engl J Med 2020 (NCT01362803) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213756s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo
• https://doi.org/10.1056/NEJMoa1912735