First New Second-line Therapy for SCLC in Australia in 20 Years

First New Second-line Therapy for SCLC in Australia in 20 Years

Industry News & Regulatory Approvals
Sep 24, 2021
Regulatory Approval

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