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Novartis Reveals Cancer Cases Possibly Linked to Gene Therapy Zolgensma
Novartis said it notified health authorities and is reviewing a potential safety signal after 6,000 patients received the gene therapy.
- On Thursday, Novartis disclosed nine reports of tumors in patients treated with Zolgensma, its spinal muscular atrophy gene therapy, with two cases showing evidence that the virus used for delivery integrated into patient DNA.
- Zolgensma, developed by AveXis, treats SMA by packaging a gene into an AAV to stimulate SMN protein production; researchers have long feared AAVs could potentially integrate into human DNA, a risk listed in therapy warnings.
- Nine reports of tumors have emerged since Zolgensma's 2019 approval, with seven cases identified recently. Cure SMA noted that three of those patients underwent testing, with one case appearing unrelated to the therapy.
- SMA Europe called the reports "deeply concerning for families," urging Novartis to provide clear information rather than leaving patients to piece together safety concerns from social media and incomplete reports.
- Regulatory authorities are now examining the cases, as the FDA previously called for greater monitoring of gene therapies following concerns involving UniQure; Novartis said it will continue working with regulators on next steps.
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14 Articles
14 Articles
The drug manufacturer Novartis has reported nine tumour cases worldwide in children who had previously been treated with special gene therapy. In two cases, there is already evidence of a relationship with the treatment.
·Vienna, Austria
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Tumors were diagnosed in nine children treated with Zolgensma, a gene therapy for a rare but serious disease.
·Montreal, Canada
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Novartis confirms 2 tumor cases appear tied to SMA gene therapy
Novartis has confirmed that there have been at least two reports of tumors that appear to have been caused by treatment with Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy that is widely approved for infants and young children with spinal muscular atrophy (SMA). Details about these cases remain murky, and advocacy organizations are urging SMA patients […]
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Total News Sources14
Leaning Left0Leaning Right3Center2Last UpdatedBias Distribution60% Right
Bias Distribution
- 60% of the sources lean Right
60% Right
C 40%
R 60%
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