Novartis Gets FDA Approval for Lutathera in Pediatric Treatment
By Dean Seal
Novartis said federal regulators have approved its Lutathera therapy as a treatment for pediatric patients with certain gastroenteropancreatic neuroendocrine tumors.
The Swiss pharmaceutical company said Tuesday that the Food and Drug Administration has approved the therapy for the treatment of patients aged 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
The approval makes Lutathera the first therapy that has been specifically reviewed and approved for use in pediatric patients with gastroenteropancreatic neuroendocrine tumors, Novartis said.
The approval was based on a trial that reported a safety profile for Lutathera that was consistent with an adult population in a previous study that ultimately got the therapy approved for adult patients.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
April 23, 2024 14:18 ET (18:18 GMT)
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