Jazz Pharma Says FDA Granted Priority Review For Zepzelca And Tecentriq Combo For ES-SCLC

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental New Drug Application (sNDA) for Zepzelca in combination with Tecentriq as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC).

The Prescription Drug User Fee Act (PDUFA) action date, or a date on which a decision from the regulator is expected on October 7, 2025.

The sNDA submission is based on results from the Phase 3 IMforte study of Zepzelca plus Genentech's Tecentriq, which met both primary endpoints, showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to Tecentriq alone.