Novartis confirmed reports of tumors in patients treated with Zolgensma, following social-media pressure from patient advocates. The company stated that nine tumor reports were received in total, with two cases showing evidence of vector integration and the remaining seven not yet causally linked. The gene therapy uses an AAV vector, and Novartis noted that the potential tumorigenicity risk from vector integration is already included in the prescribing information. Still, the timing distribution described by advocates—reported as 18–60 months after dosing—raises the practical question of post-treatment monitoring cadence. For industry, the immediate watch items are any changes in risk management strategy, long-term follow-up outcomes in registries, and whether regulators request additional post-marketing data to further quantify integration-linked versus background tumor incidence.