.
- Einreichung in den USA für Patienten mit rezidivierenden indolenten B-Zell-Non-Hodgkin-Lymphomen (iNHL)
- In der EU Zulassung für rezidivierendes Marginalzonenlymphom (MZL) beantragt, einem Subtyp vom iNHL
- Die Anträge stützen sich auf die Ergebnisse der Phase-III-Studie CHRONOS-3, die der Kombination aus Copanlisib und Rituximab bei Patienten mit iNHL eine signifikante Verbesserung beim progressionsfreien Überleben bescheinigen
Bayer hat für die Kombination von Copanlisib mit Rituximab zur Anwendung bei bestimmten Subtypen von indolenten Non-Hodgkin-Lymphomen (iNHL) in den USA und der EU die Zulassung beantragt. Der Antrag auf Indikationserweiterung (sNDA; supplemental new drug application) bei der US-Zulassungsbehörde Food and Drug Administration (FDA) bezieht
- Einreichung in den USA für Patienten mit rezidivierenden indolenten B-Zell-Non-Hodgkin-Lymphomen (iNHL)
- In der EU Zulassung für rezidivierendes Marginalzonenlymphom (MZL) beantragt, einem Subtyp vom iNHL
- Die Anträge stützen sich auf die Ergebnisse der Phase-III-Studie CHRONOS-3, die der Kombination aus Copanlisib und Rituximab bei Patienten mit iNHL eine signifikante Verbesserung beim progressionsfreien Überleben bescheinigen
Bayer hat für die Kombination von Copanlisib mit Rituximab zur Anwendung bei bestimmten Subtypen von indolenten Non-Hodgkin-Lymphomen (iNHL) in den USA und der EU die Zulassung beantragt. Der Antrag auf Indikationserweiterung (sNDA; supplemental new drug application) bei der US-Zulassungsbehörde Food and Drug Administration (FDA) bezieht
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