Novartis confirmed nine reported tumor cases in patients treated with Zolgensma and provided an update on investigational context. The company said two cases show evidence of vector integration into patient DNA, while seven reports have not been causally linked to the therapy. The disclosure follows renewed patient-advocate scrutiny on social media and highlights how gene therapy long-term surveillance continues to shape benefit-risk discussions. Novartis also noted that the potential risk of tumorigenicity from vector integration is included in Zolgensma prescribing information. For developers and regulators, the update reinforces the need for transparent pharmacovigilance systems and follow-up design that can interpret integration signals alongside background cancer incidence. Clinicians managing SMA patients will likely watch for any updates that clarify causality, timing, tumor histology patterns, and whether risk changes for specific dosing or subgroups.
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