- 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.
- 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.