FDA Probes Cancer Risk After Tumours Emerge In Children Treated With Novartis’ SMA Gene Therapy

The US Food and Drug Administration (FDA) is looking into a possible cancer risk linked to Zolgensma, a gene therapy made by Swiss drugmaker Novartis. The move comes after the company reported several cases of tumours in patients who had received the treatment. These included two children under the age of two with spinal muscular atrophy (SMA), in whom investigators found evidence linking the tumour to the therapy.

Zolgensma is a one-time treatment for children under two with SMA, a rare genetic disorder that slowly weakens the muscles. More than 6,000 patients have received it since it was approved in 2019.

In two cases, tests on tumour tissue showed that DNA from the therapy’s viral vector, the carrier used to deliver the treatment into the body, had entered the patients’ genes at a spot called GLI1. This gene can drive cancer when it is switched on. The FDA said it is also looking into a third tumour linked to GLI1.

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The tumours were found in the brain and nerves, the spine and the area around it, and the kidney.

The agency is now deciding…

Original source: https://www.timesnownews.com/lifestyle