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PR Newswire is an important news source that can be accessed via the X-Billboard. It is part of the Newswire Hub, which bundles important international news sources for stock market participants in one central location. If you want to get a quick overview, you can easily scroll through the headlines. If you want to look at the news in more detail, you can use the detailed views of the info cards to directly access the respective news item and other analysis tools.
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ES0169501022
State: 17.08.2024 | 11PM
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FIGI: BBG000F3LRQ5
PHM
Pharma Mar, S.A.
GICS: 35201010 · Sector: Consumer Goods - Pharmacy Products and Biotechnology · Sub-Sector: -
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Pharma Mar, S.A.
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ES0169501022
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PHM
MIC
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REUTERS
PHM.MC
BLOOMBERG
PHM SM
Wed, 16.10.2024       Pharma Mar
ES0169501022

Jazz plant die Einreichung eines ergänzenden Zulassungsantrags (sNDA) bei der US-Arzneimittelbehörde (FDA) und PharmaMar wird in der ersten Hälfte des Jahres 2025 bei der Europäischen Arzneimittelagentur (EMA) einen Zulassungsantrag für diese Kombinationstherapie als Erstlinien-Erhaltungstherapie für ES-SCLC einreichen.

MADRID, 16. Oktober 2024 /PRNewswire/ -- PharmaMar (MSE: PHM) und sein Partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ) haben heute positive Ergebnisse der klinischen Phase-3-Studie bekannt gegeben, in der Zepzelca® (Lurbinectedin) in Kombination mit dem PD-L1-Inhibitor Atezolizumab (Tecentriq®) im Vergleich zu Atezolizumab allein als Erhaltungstherapie für Erwachsene mit kleinzelligem Lungenkrebs im fortgeschrittenen Stadium (ES-SCLC) nach einer Induktionstherapie mit Carboplatin, Etoposid und Atezolizumab untersucht wurde. Die Kombination von Lurbinectedin und Atezolizumab zeigte eine statistisch signifikante Verbesserung der primären Endpunkte Gesamtüberleben (OS) und progressionsfreies Überleben (PFS), wie von einer unabhängigen Prüfeinrichtung (IRF) bewertet, im Vergleich zur Behandlung mit Atezolizumab allein.

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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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