Novartis disclosed additional tumor reports in children treated with Zolgensma (onasemnogene abeparvovec), confirming nine total cases since approval in 2019, including seven newly disclosed reports. The company said two cases show evidence of vector DNA integration into patient DNA and noted the prescribing information already includes a theoretical tumorigenicity risk from AAV vector integration. The disclosure sharpens ongoing post-marketing scrutiny of AAV-based gene therapies, with implications for long-term monitoring, patient counseling, and how regulators and sponsors manage rare-but-serious adverse events when integration signals are detected.