Novartis confirmed additional tumor cases in children treated with its spinal muscular atrophy gene therapy Zolgensma, reporting nine cases in total so far, including evidence of AAV vector DNA integration in two patients. The company said it has notified health authorities and that vector integration risk is included in the therapy’s prescribing information. Regulators and clinicians increasingly face a difficult balancing act: AAV gene therapies can be transformative for SMA, but growing post-marketing signals are forcing more intensive surveillance and clearer guidance on how to evaluate suspected tumorigenicity. The latest disclosure is likely to influence ongoing post-approval studies and monitoring protocols across AAV platforms, while raising pressure for faster mechanistic clarity on which events translate into clinical risk.