FDA says it is investigating serious malignancy risk linked to Zolgensma gene therapy
NVS•The FDA is investigating a serious malignancy risk linked to Zolgensma and monitoring similar gene therapy programs; it said no neoplasia cases have been reported after Itvisma and that the therapies’ benefits continue to outweigh their potential risks for approved uses.
1. FDA safety monitoring
The FDA is investigating a serious malignancy risk linked to Zolgensma and closely monitoring neoplasia, including malignancy, in other similar AAV vector-based gene therapy programs. The agency said there have been no reported cases of neoplasia following Itvisma administration to date, and that the overall benefits of Zolgensma and Itvisma continue to outweigh their potential risks for approved uses.
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