Jazz Pharmaceuticals Annouced Zepzelca® And Tecentriq® Combination Secures U.S. FDA Priority Review For First-Line Maintenance Therapy In Advanced Small Cell Lung Cancer

Jazz Pharmaceuticals plc has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after completing initial treatment with atezolizumab, carboplatin, and etoposide. The application has been granted Priority Review, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025.

Priority Review is designated for drugs that may offer significant improvements in the treatment or diagnosis of serious conditions. The sNDA submission is supported by data from the Phase 3 IMforte trial, which evaluated the efficacy of Zepzelca in combination with atezolizumab compared to atezolizumab alone as maintenance therapy. The trial met both of its primary endpoints, showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS).

Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, said in a statement, "The FDA's Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need. We are pleased to have received this review designation after presenting the IMforte trial data at ASCO 2025 with simultaneous publication in The Lancet. Together, these milestones bring us a step closer to potentially offering patients a new first-line maintenance option that could help extend the time they live without their disease progressing.”

In the trial, patients who had not experienced disease progression after four cycles of induction therapy with carboplatin, etoposide, and atezolizumab were randomized to receive either the combination of Zepzelca and atezolizumab or atezolizumab alone. From the point of randomization, the median PFS was 5.4 months for the combination group compared to 2.1 months for the atezolizumab-alone group, representing a 46% reduction in the risk of disease progression or death (stratified HR = 0.54; 95% CI: 0.43–0.67; p < 0.0001). 

Median OS was 13.2 months for the combination versus 10.6 months for atezolizumab alone, indicating a 27% reduction in the risk of death (stratified HR = 0.73; 95% CI: 0.57–0.95; p = 0.0174). The safety profile of the Zepzelca and atezolizumab combination was consistent with previously reported data, with no new or unexpected safety findings observed in the study.