Ireland-based pharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) announced on Thursday that the US Food and Drug Administration (FDA) has granted approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

This is the first approved combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options.

The FDA approval is based on results from the Phase 3 IMforte trial, which showed that the Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. These results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet.

The National Comprehensive Cancer Network (NCCN) has updated the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for SCLC to include the Zepzelca and atezolizumab combination as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.