Novartis confirmed it has received nine reports of tumors in children previously treated with its spinal muscular atrophy gene therapy Zolgensma, with two cases showing evidence the tumors may be linked to the treatment, raising a renewed safety flag. Patient advocates said additional cases were shared with clinicians and families after earlier disclosures. The company emphasized that the risk of tumorigenicity is already included in Zolgensma’s prescribing information, reflecting theoretical concerns about adeno-associated viral (AAV) vector integration. Advocates and regulators are now examining the potential link between vector integration and later tumor development. For the gene therapy sector, the update underlines the importance of long-term surveillance plans and transparency in post-authorization safety reporting—particularly for AAV-based platform therapies used in pediatric populations. Clinicians are expected to continue monitoring patients and reviewing any emerging patterns, while families weigh information from new reports against established label warnings and monitoring protocols.