Novartis disclosed nine total tumor reports in children treated with its spinal muscular atrophy gene therapy Zolgensma, including seven newly disclosed cases. The company said two cases showed evidence of vector integration into patient DNA, and emphasized that timely notifications were made to health authorities. The update reiterates that a theoretical risk of tumorigenicity due to AAV vector integration is already included in the Zolgensma prescribing information. The disclosures renew scrutiny of long-term safety monitoring and integration biology for AAV-delivered therapies. For the gene-therapy field, the incident sharpens the focus on risk communication and post-approval surveillance as more AAV programs mature through broader pediatric use.