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Novartis cites previously unknown tumor cases possibly tied to gene therapy
STAT • • business
Key Points:
- Novartis has revealed seven previously unknown cases of tumors in children treated with its spinal muscular atrophy therapy, Zolgensma, raising safety concerns among families, physicians, and advocacy groups.
- The cases are currently considered a potential safety signal and were publicized by an advocacy group and on social media after Novartis informed neurologists earlier this week.
- SMA Europe stated that regulatory authorities are now investigating the reported tumor cases linked to the treatment.
- Since Zolgensma's approval in 2019, Novartis has received nine tumor reports in treated patients, with two cases showing possible links to the therapy itself.
