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.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.