Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The submission received Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of October 7, 2025. The application is supported by results from the Phase 3 IMforte trial, where the combination therapy showed significant improvements in both progression-free survival and overall survival compared to atezolizumab alone. “The FDA’s Priority Review designation highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer,” said Dr. Rob Iannone, Executive Vice President and Chief Medical Officer at Jazz Pharmaceuticals.
The IMforte trial enrolled patients whose disease had not progressed after initial induction therapy with atezolizumab, carboplatin, and etoposide. Median progression-free survival was 5.4 months for the Zepzelca–atezolizumab group versus 2.1 months for atezolizumab alone. Median overall survival was 13.2 months versus 10.6 months, respectively. No new safety concerns were identified. Zepzelca, already approved for relapsed SCLC under accelerated approval, is also being studied in a confirmatory trial, LAGOON, to support potential full FDA approval.
