Health · Pharma & Biotech · 2 hrs ago
Novartis reports seven newly identified tumors in Zolgensma patients
Novartis says it has received nine reports of tumors in patients treated with Zolgensma, its gene therapy for spinal muscular atrophy.
The reports involve patients who received the treatment after it was approved in 2019.
Seven cases were previously unknown, and the company disclosed them to neurologists earlier this week.
In two cases, there is evidence the tumors may be linked to the treatment.
For now, the cases are considered a potential safety signal, not proof that Zolgensma caused the tumors.
The reports have raised concern among families, doctors and patient advocacy groups.
Regulatory authorities are examining the cases, according to SMA Europe.
Novartis has reported seven previously unknown tumor cases in children treated with its spinal muscular atrophy therapy Zolgensma.
The company said it has received nine tumor reports among patients treated since the drug was approved in 2019.
Two cases have shown evidence that the tumors may be linked to the treatment.
The cases are being treated as a potential safety signal, and regulatory authorities are examining them.
The cases were publicized on Thursday after Novartis disclosed them to neurologists earlier in the week.
- Who
- Novartis and children treated with its Zolgensma therapy.
- What
- Seven previously unknown tumor cases were reported. Novartis said it has received nine tumor reports in total.
- When
- The cases were publicized on Thursday, November 5, 2026. Novartis had disclosed the information to neurologists earlier that week.
- Where
- Not stated
- Why
- The tumors may be a potential safety signal for Zolgensma. Two cases showed evidence of a possible link to the treatment.
This story does not have two clearly opposing sides.
Zolgensma was approved.
Novartis disclosed information about the cases to neurologists.
An advocacy group and a Facebook page publicized the cases, and SMA Europe said regulatory authorities were examining them.
- New cases
- Seven previously unknown tumor cases
- Total reports
- Nine tumor reports among treated patients
- Possible treatment link
- Two cases showed evidence of a possible link
- Drug
- Zolgensma, Novartis’s spinal muscular atrophy therapy
- Approval
- 2019