The U.S. Food and Drug Administration granted expedited approval to the combination of Jazz Pharmaceuticals' Zepzelca (lurbinectedin) and Roche's Tecentriq (atezolizumab) as a first-line maintenance therapy for adults with extensive-stage small-cell lung cancer who have not progressed following initial treatment. This marks the first combination therapy approved in this maintenance setting. Data from the Phase III Imforte trial demonstrated a 46% reduction in the risk of disease progression or death and a 27% reduction in overall mortality compared to atezolizumab alone. The decision arrived ahead of the scheduled PDUFA date, reflecting the unmet need for improved therapies in this aggressive cancer.
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