Selumetinib

(Koselugo®)

Koselugo®

Drug updated on 12/11/2024

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% confidence interval (CI): 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 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 NF1, the studies focused on children aged 2 years and older with inoperable or progressive plexiform neurofibromas. In 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