Tumor risk in Novartis gene therapy under scrutiny

Nine tumor cases have been reported in patients who received Novartis's multi-million-dollar gene therapy, prompting the U.S. Food and Drug Administration to open a review of the treatment's safety. The Swiss drugmaker's therapy, among the most expensive one-time treatments on the market, is now under scrutiny over whether the inserted genetic material may be linked to cancer. The FDA's action follows the reports and could affect how the therapy is prescribed and monitored. Investors and clinicians will watch for the agency's findings and any label changes, as well as Novartis's response and whether other gene therapies face similar reviews.