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State: 17.08.2024 | 11PM
Tue, 15.10.2024       Pharma Mar
ES0169501022

Jazz plans to submit supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and PharmaMar will submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in first half of the year 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC. 

MADRID, Oct. 15, 2024 /PRNewswire/ -- PharmaMar (MSE: PHM) and its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ)  have announced today positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq®) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage Small Cell Lung Cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

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