Selumetinib

(Koselugo®)

Selumetinib

Drug updated on 10/28/2024

Dosage FormCapsule (oral; 10 mg, 25 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Selumetinib demonstrated an overall efficacy of 71.77% (95% CI (confidence interval): 63.24-81.45%) in late-stage/metastatic non-small cell lung cancer (NSCLC), with better efficacy when administered alone (74.08%) compared to combined therapy (65.20%). It also showed higher efficacy than chemo- or immune therapies, though this difference was not statistically significant.
  • In neurofibromatosis type 1 (NF1)-associated tumors, selumetinib had a partial response rate of 68%-71% for inoperable or progressive plexiform neurofibromas in children 2 years and older. This was superior to the response rate of bevacizumab (36%-41%) for vestibular schwannomas in patients with neurofibromatosis type 2 (NF2).
  • Selumetinib had an overall serious adverse event (SAE) rate of 42.96% (95% CI: 34.74-53.13%) in non-small cell lung cancer (NSCLC) patients. When used alone, selumetinib had a significantly better safety profile with an SAE rate of 10.49%, compared to 47.38% for combined therapy.
  • Placebo Comparison: In the network meta-analysis for NSCLC, placebo had the best safety profile, followed by selumetinib, chemotherapy, and immune therapy.
  • The NSCLC studies primarily involved older adults with a mean age of 62 years and a performance status (PS) of 0-2. For neurofibromatosis type 1 (NF1), the studies focused on children aged 2 years and older with inoperable or progressive plexiform neurofibromas. In neurofibromatosis type 2 (NF2), the studies included patients 12 years of age and older with vestibular schwannomas. There were no specific findings related to subgroups based on other demographic or clinical characteristics.

Product Monograph / Prescribing Information

Document TitleYearSource
Koselugo (selumetinib) Prescribing Information.2024AstraZeneca Pharmaceuticals LP., Wilmington, DE

Systematic Reviews / Meta-Analyses