FDA Approves Lutetium Lu 177 Dotatate in Pediatric SSTR+ GEP-NETs

The FDA has approved lutetium Lu 177 dotatate (Lutathera) for patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to a press release by the agency.¹

The indication also includes patients with foregut, midgut, and hindgut neuroendocrine tumors. The approval is based on results from the phase 2 NETTER-P trial (NCT04711135), of which pharmacokinetics, dosimetry, and safety data were evaluated. The trial is still ongoing. This trial focused on pediatric patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma.

The efficacy portion was based on results from the phase 3 NETTER-1 trial (NCT01578239), assessing 229 patients with locally advanced/inoperable or metastatic SSTR-positive midgut carcinoid tumors.

In the NETTER-P trial, 9 pediatric patients were assessed, including 4 with GEP-NETs. The trial focused on outcomes including absorbed radiation doses in target organs and incidence of adverse effects (AEs) after the first cycle of treatment. Investigators also looked into short-term AEs after treatment. The safety profile of the agent among pediatric patients was similar to that observed in the adult population.

Lu 177 dotatate was given at a recommended dose of 7.4 GBq every 8 weeks, plus or minus 1 week for 4 cycles. In order to assess the long-term outcomes of this treatment, a post-marketing requirement was issued.

Previously, this treatment was approved by the FDA in January 2018 for the adult population.² In January 2024, the FDA accepted an abbreviated new drug application for Lu 177 dotatate under the same indication.³

References

1. FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS. News release. FDA. April 23, 2024. Accessed April 23, 2024. https://shorturl.at/swJLY
2. FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS. News release. FDA. January 26, 2018. Accessed April 23, 2024. https://bit.ly/4aR8aDB
3. Lantheus announces acceptance of its first-to-file ANDA for generic LUTATHERA® (Lutetium Lu 177 Dotatate). News release. Lantheus Holdings. January 11, 2024. Accessed April 23, 2024. https://yhoo.it/3TSxTp7