Dr. Sands on the FDA Approval of Lurbinectedin in Small Cell Lung Cancer

Jacob Sands, MD, physician, Dana-Farber Cancer Institute, instructor in medicine, Harvard Medical School, discusses the FDA approval of lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression, following platinum-based chemotherapy.

The agent was approved under the FDA's “Accelerated Approval” Program, which allows for the conditional approval of a therapy that fills an unmet need for a serious or life-threatening disease or condition. The regulatory decision is based on data from a phase 2 basket trial (NCT2454972) of 105 patients with SCLC who progressed on platinum-containing therapy.

Results from the trial showed that the agent led to an overall response rate (ORR) of 35.2%. Additionally, the disease control rate was 68.6% (95% CI, 58.8%-77.3%). It has been difficult to develop an effective and tolerable second-line therapy for patients with resistant and rapidly progressive SCLC, explains Sands. The approval of lurbinectedin has helped to close this area of unmet need, concludes Sands.