STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy — SkimNews
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- Novartis disclosed to neurologists earlier this week that seven previously unknown tumor instances had been found in children treated with Zolgensma.
- SMA Europe publicized the cases on Thursday, alongside a Facebook page, after Novartis had already informed neurologists.
- SMA Europe said regulatory authorities are now examining the seven cases.
- Novartis said it had received nine reports of tumors in previously treated patients since Zolgensma’s approval in 2019.
- Novartis said two of the nine cases showed evidence that the tumors may be linked to Zolgensma itself.
Why it matters: For families and treating neurologists, the disclosure supplies a concrete safety concern: seven newly acknowledged cases sit within nine total tumor reports since Zolgensma’s 2019 approval, and regulators are examining them. Novartis says two cases show evidence of a treatment link, while the broader set remains only a potential concern.
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