The U.S. Food and Drug Administration has granted early approval for Jazz Pharmaceuticals' and Roche's combination therapy of Zepzelca (lurbinectedin) with Tecentriq (atezolizumab), including Tecentriq Hybreza variant, as first-line maintenance treatment for adults with extensive-stage small-cell lung cancer who have not progressed after first-line induction therapy. This marks the first approved combination therapy for maintenance in this indication. The regulatory decision is supported by phase III Imforte study data demonstrating a 46% reduction in disease progression or death risk and a 27% reduction in mortality risk compared to atezolizumab alone. The move arrived ahead of the planned October 7 PDUFA deadline, signaling a significant advancement in lung cancer treatment options.