Novartis disclosed seven previously unknown tumor cases in patients treated with its spinal muscular atrophy therapy, Zolgensma, following an alert publicized by SMA Europe. The drugmaker confirmed it has received a total of nine tumor reports since the treatment received approval in 2019. Medical experts and health agencies are now evaluating whether the therapy directly contributed to these malignancies. To date, Novartis has acknowledged that two of the total reported cases show evidence suggesting a possible connection to the treatment.
Key points
Evidence suggests that at least two of the reported tumor cases may be directly linked to…: Evidence suggests that at least two of the reported tumor cases may be directly linked to Zolgensma treatment.
The emergent tumor reports are currently being treated as a potential safety signal for t…: The emergent tumor reports are currently being treated as a potential safety signal for the gene therapy.
Medical professionals and patient advocacy groups are raising serious safety concerns as…: Medical professionals and patient advocacy groups are raising serious safety concerns as regulatory reviews get underway.
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Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, a surprising development that has raised concerns among families, physicians, and patient advocacy groups.
The cases, which for the moment are being seen as only a potential safety signal, were publicized on Thursday by an advocacy group and on a Facebook page after Novartis earlier this week disclosed the information to neurologists. One advocacy group, SMA Europe, issued a statement saying that regulatory authorities are now examining the cases.
The drugmaker issued its own statement saying that, since its treatment — called Zolgensma — was approved in 2019, it has received nine reports of tumors in previously treated patients. Of those, two cases to date showed evidence that the tumors may be linked to the treatment itself.
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