Jazz Pharmaceuticals plc has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for Priority Review. This application is for its use as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial therapy. The Priority Review status signifies the potential of the drug combination to significantly improve treatment outcomes for this serious condition. The Prescription Drug User Fee Act (PDUFA) action date is set for October 7, 2025. The application is supported by data from the IMforte Phase 3 trial, which demonstrated notable improvements in progression-free and overall survival.
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