Novartis Reports Tumor Cases Linked to Gene Therapy
By Adria Calatayud
Novartis said it received nine reports of tumors in patients treated with its gene therapy Zolgensma since the drug was approved in 2019, including two with evidence linking them to the medicine.
The Swiss drugmaker said both patients underwent treatment and continue to be monitored.
"Patient safety is our priority. In each case, we timely and appropriately notified health authorities and will continue to work with them on next steps," the company said.
Zolgensma is a one-time treatment for a rare infant muscle-wasting disease called spinal muscular atrophy, or SMA. Gene therapies like Zolgensma are designed to introduce new DNA into the body to address the genetic root of a disease.
Novartis said the potential risk of tumors due to integration of the genetic material delivered by the medicine is currently included in Zolgensma's prescribing information. More than 6,000 patients have been treated with the drug across clinical trials, managed-access programs and commercial treatment, the company said.
SMA Europe, an organization of SMA patient groups, said it was aware of the reports of tumors in children previously treated with Zolgensma and that it understood relevant regulatory authorities were actively involved.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
November 06, 2026 07:19 ET (12:19 GMT)
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