Novartis disclosed additional reports of tumors in children treated with its spinal muscular atrophy gene therapy Zolgensma, with the company now acknowledging seven previously unknown cases. The disclosures were prompted by patient-advocacy and physician outreach, with regulators described as examining the safety signal. In Novartis’ statement, the company said it has received nine total tumor reports in previously treated patients since approval in 2019, with evidence suggesting a potential link in two cases to date. Seven other reported cases are not yet causally connected, and the company noted that the tumor risk from AAV vector integration is included in the prescribing information. The development raises immediate attention for long-term pharmacovigilance and may influence how clinicians counsel families and monitor children after AAV-based therapies as post-approval follow-up matures.