Novartis' SMA drug may have caused cancer-related illnesses

The FDA has reported potential links between Novartis' gene therapy Zolgensma and cancer cases in treated patients. Investigations revealed that the viral vector used in the therapy may integrate into patients' DNA, possibly leading to tumor development. Three cancer cases associated with the GLI1 gene have been identified, with two showing viral genetic material integrated near the gene, potentially enhancing its activity. Novartis has faced criticism for delays in disclosing these findings. The FDA is also assessing risks related to another therapy, Itvisma, which uses the same viral vector. Despite these concerns, the FDA maintains that the benefits of both therapies outweigh the risks, urging continued monitoring for cancer development in patients.