FDA Approves Lu-177 DOTATATE for Pediatric Patients with GEP-NETS

April 25, 2024

On April 23, 2024, the Food and Drug Administration (FDA) approved lutetium-177 DOTATATE (Lutathera; AAA/Novartis) for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (SSTR GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. This is an expansion of FDA's 2018 approval for GEP-NETs in adults.

This represents the first FDA approval of a radiopharmaceutical for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.

Read the full FDA approval here.