Lurbinectedin receives accelerated FDA approval for SCLC

  • U.S. Food and Drug Administration

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Lurbinectedin (Pharma Mar SA) has received accelerated approval from the FDA for adults with metastatic small cell lung cancer (SCLC) with disease progression during or after receipt of platinum-based chemotherapy.

Why this matters

  • Lurbinectedin received orphan drug status; this FDA approval was 2 months ahead of the goal date.

Key points

  • Approval is based on results from a multicenter, open-label, multicohort study:
    • 105 patients with metastatic SCLC and disease progression during or after receiving platinum-based chemotherapy.
    • Overall response rate was 35.2%, and median duration of response was 5.3 months.
    • Stable disease was reported in 33% of patients and was higher in those with a chemotherapy-free interval of ≥90 days (37% vs 29%).
    • Median OS (9.3 months) and PFS (3.5 months) were longer in patients with a chemotherapy-free interval of ≥90 days.
  • Most common adverse events included myelosuppression, fatigue, nausea, decreased appetite, musculoskeletal pain, constipation, dyspnea, vomiting, cough, and diarrhea.
  • Recommended dosage is 3.2 mg/m2 every 21 days.
  • The phase 3 ATLANTIS trial now underway.
  • Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.

Prescribing information.