France’s medicines agency says that, so far, no child treated with Zolgensma in France is affected by the serious adverse events raised after nine tumour cases were reported worldwide. That matters for French families, but it does not settle the safety question: the European Medicines Agency is opening a new assessment to clarify the signal and what it may mean for long-term monitoring.
Franceinfo reports that Novartis said on 6 November that nine tumour cases had been recorded over seven years among more than 6,000 children treated worldwide since the medicine entered the US market in 2019. The available material does not establish that Zolgensma caused those tumours. It also does not provide the clinical files, the intervals between treatment and diagnosis, or the analysis behind the reported cases.
That is why the absence of reported French cases and the European review answer different questions. The French agency, ANSM, is describing the current situation among patients followed in France. The European assessment is intended to characterise the risk, including the tumour types involved, when they appeared, possible contributing factors and implications for long-term surveillance.
ANSM says no change to patient care or follow-up is currently recommended, while enhanced monitoring of the medicine continues. French and US health authorities, together with AFM-Telethon, maintain that Zolgensma’s benefits outweigh the risk of serious adverse effects.
That benefit-risk judgment does not remove the need to explain the safety signal. For a gene therapy given early in life, long-term follow-up is as material as early treatment benefit. The meaningful next development will be the European assessment’s account of what the nine cases do, or do not, require in monitoring children who have received the treatment.
Sources
- franceinfo Tous titres · Source date: 2026-11-13
Independent editorial content. WUA is not affiliated with any political party. 2026-11-13