US regulator investigates tumour risk in children given Novartis gene therapy

The US ⁠Food and Drug Administration said ⁠on Friday it was investigating a ⁠risk of neoplasia, or tumour formation including malignancy, associated with Novartis’ gene therapy Zolgensma.

The Swiss drug maker earlier in the day disclosed two cases in which tumours in children showed evidence of being linked to its gene therapy drug used to treat patients less than ‌two years old with spinal muscular atrophy.

Novartis said that it had received nine reports overall of tumours in patients...