FDA Accepts Jazz Pharma's sNDA For Zepzelca In Combination With Atezolizumab As First-Line Maintenance Treatment For People With ES-SCLC For Priority Review, With PDUFA Action Date Of October 7, 2025

Target Action (PDUFA) Date set for October 7, 2025

Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in both progression-free and overall survival in the ES-SCLC first-line maintenance setting

Jazz to host investor webcast on Tuesday, June 10 at 4:30 p.m. EDT / 9:30 p.m. IST to review Zepzelca data

For U.S. media and investors only

DUBLIN, June 10, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025. Priority Review is granted to applications for drugs that have the potential to significantly improve the treatment, prevention, or diagnosis of serious conditions.