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)
Copyright (c) 2024 Dow Jones & Company, Inc.-
How Anti-Obesity Drugs Are Innovating the Healthcare Market
-
What’s Happening In the Markets This Week
-
Why Immigration Has Boosted Job Gains and the Economy
-
What to Invest in During High Inflation
-
Never Mind Market Efficiency: Are the Markets Sensible?
-
Starbucks Stock Could Use a Pick-Me-Up After Big Selloff; Is it a Buy?
-
5 Cheap Stocks to Buy From an Attractive Part of the Market
-
Markets Brief: All Eyes On Inflation
-
After Earnings, Is Lyft Stock a Buy, a Sell, or Fairly Valued?
-
8 Stock Picks in the Apparel Industry
-
Baidu Earnings: Advertising Weakness Offset by Continued Growth In Cloud Business
-
Going Into Earnings, Is Target Stock a Buy, a Sell, or Fairly Valued?
-
Walmart Earnings: Low Prices and Strong Digital Presence Drive Market Share Gains
-
After Earnings and a Big Selloff, Is Shopify Stock a Buy, a Sell, or Fairly Valued?
-
Cisco Earnings: Positive Guidance and Splunk Inclusion Align With Our Long-Term Thesis
-
3 Warren Buffett Stocks to Buy After Berkshire Hathaway’s Just-Released 13F Filing