STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy
Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, Zolgensma.
Novartis has admitted to seven previously unknown cases where tumors were discovered in children who received its spinal muscular atrophy therapy, a revelation that has caused alarm among families, medical professionals, and patient advocacy organizations. The instances, currently being treated as potential safety concerns, were disclosed by an advocacy group and Facebook page on Thursday following Novartis's earlier communication of the information to neurologists.
SMA Europe, an advocacy group, stated that regulatory agencies are currently investigating the cases. Novartis, in their own statement, revealed they have received nine reports of tumors in patients who had previously received their treatment, known as Zolgensma, which was approved in 2019. Out of these nine reports, two cases have shown evidence suggesting a possible link between the tumors and the therapy.
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