Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy

Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported.

The cases were brought to light by an advocacy group and a Facebook post after the company informed neurologists earlier in the week. The tumors are being treated as a potential safety signal pending further investigation.

Regulatory authorities have begun reviewing the reports, and patient groups have expressed concern. Novartis noted that Zolgensma was approved in 2019 and reiterated its commitment to safety.