Lurbinectedin

(Zepzelca®)

Zepzelca®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 4 mg)
Drug ClassAlkylating drugs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

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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]
  • Lurbinectedin demonstrated improved overall survival in platinum-sensitive cell lung cancer (SCLC) compared to oral topotecan (hazard ratio (HR): 0.43; 95% CrI: 0.27, 0.67), IV (intravenous) topotecan (HR: 0.43; 95% CrI: 0.26, 0.70), and platinum re-challenge (HR: 0.42; 95% CrI: 0.30, 0.58).
  • A systematic review involving 6349 patients assessed various treatments, including tyrosine kinase inhibitors (TKIs), topoisomerase I inhibitors, checkpoint inhibitors (CPIs), alkylating agents, and others. Promising phase 2 results were observed for TKIs and liposomal irinotecan, but no phase 3 data were available, and the clinical potential of CPIs and alkylating agents remains unclear.
  • The effectiveness findings apply exclusively to platinum-sensitive SCLC patients, with no other subgroups or population types mentioned.
  • Favorable Safety Profile in Platinum-Sensitive Patients: Lurbinectedin demonstrated a favorable safety profile compared to oral and IV topotecan, and platinum re-challenge in platinum-sensitive SCLC patients, with no specific adverse effects reported in the study.
  • General Safety Concerns in Relapsed SCLC Treatments: 69% of reviewed publications reported low-/very-low-quality evidence due to issues such as lack of randomization and small sample sizes; specific adverse effects for lurbinectedin or other treatments were not provided.

Product Monograph / Prescribing Information

Document TitleYearSource
Zepzelca (lurbinectedin) Prescribing Information.2023Jazz Pharmaceuticals, Inc., Palo Alto, CA

Systematic Reviews / Meta-Analyses