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# Jazz Plans sNDA for Zepzelca in Lung Cancer
- URL: https://www.fdaweb.com/jazz-plans-snda-for-zepzelca-in-lung-cancer/
- Published: 2024-10-15T12:00:00.000Z
- Updated: 2026-09-14T14:44:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157985

Jazz Pharmaceuticals says it will file a supplemental NDA next year following “positive top-line results” from its Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Roche’s Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer following induction therapy with carboplatin, etoposide and atezolizumab. The company says the Zepzelca combination showed statistically significant improvement in the primary endpoints of overall survival and progression-free survival compared to treatment with atezolizumab alone.

The combination was generally well-tolerated, it says, adding that preliminary safety data in the ongoing trial was consistent with the known safety profiles of Zepzelca and atezolizumab with no new safety signals observed in the combination arm. 

Jazz and Roche plan to present the data at a future medical meeting.