SEPTEMBER 14, 2021—Lurbinectedin received approval from the Therapeutic Goods Administration (TGA) as treatment for patients with metastatic SCLC who experienced disease progression during or after receipt of platinum-based chemotherapy.
The TGA collaborated with the U.S. Food and Drug Administration (FDA) through Project Orbis to accelerate Australian approval under a provisional regulatory pathway.
Approval was based on an open-label, multicenter, single-arm phase II study of 105 patients with SCLC who had experienced disease progression after receiving a platinum-based chemotherapy. Overall response was seen in 37 patients (35.2%; 95% CI: 26.2-45.2) and the median duration of response was 5.3 months (both measured by investigator assessment. Median follow-up was 17·1 months (IQR 6.5–25.3). The most common grade 3–4 adverse events anemia, leucopenia, neutropenia, and thrombocytopenia; the latter two were the most common of the serious treatment-related adverse events, which occurred in 10% of patients, with no deaths.
Continued approval is dependent on a larger trial with some Australian sites. The trial is expected to be completed in 2025.
For a more comprehensive overview of the state of research in SCLC, read the ILCN article by Dr. Carl Gay.