Novartis confirmed additional reports of tumors in children treated with its spinal muscular atrophy gene therapy Zolgensma, bringing the total to nine cases since the therapy’s approval in 2019. The company disclosed that two of the reported cases have evidence of vector DNA integration into patient DNA. The disclosures reiterate that AAV vector integration and tumorigenicity risks are included in Zolgensma’s prescribing information, while the clinical relevance of individual integration events remains uncertain. Patient families and advocates have raised concerns about transparency and monitoring. For gene therapy stakeholders, the central operational takeaway is tighter post-treatment surveillance and continued dialogue with regulators on how to characterize and communicate rare tumor events linked to AAV vectors.