Novartis has acknowledged seven previously unknown instances of tumors found in children treated with its spinal muscular atrophy therapy, Zolgensma. This development has raised concerns among families, physicians, and patient advocacy groups.
The cases are currently regarded as a potential safety signal and were publicized by an advocacy group and on a Facebook page after Novartis disclosed the information to neurologists. SMA Europe, one of the advocacy groups, stated that regulatory authorities are now examining the cases.
Since Zolgensma’s approval in 2019, Novartis has received nine reports of tumors in previously treated patients, with two cases showing evidence that the tumors may be linked to the treatment itself. Stakeholders will need to monitor the situation closely as further investigations unfold.
Source: statnews.com · Image: Gene therapy press conference by Unknown photographer, Public domain, via Wikimedia Commons
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