Jazz Pharmaceuticals announces FDA approves Zepzelca in ES-SCLC

Jazz Pharmaceuticals (JAZZ) “announced that the FDA has granted approval for Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs as a maintenance treatment for adults with extensive-stage small cell lung cancer, or ES-SCLC, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approval marks the first 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 (NCT05091567), 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. Following four cycles of induction therapy, from the point of randomization the median overall survival for the Zepzelca and atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone. From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43-0.67; pless than0.0001). These results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet.”